13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04150549 (ClinicalTrials.gov) | June 2023 | 11/10/2019 | FMT for MS Patients | Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial | Multiple Sclerosis | Biological: Fecal Microbial Transplants | Lawson Health Research Institute | NULL | Not yet recruiting | 18 Years | 55 Years | All | 34 | Phase 2 | NULL |
| 2 | NCT05740722 (ClinicalTrials.gov) | March 1, 2023 | 30/1/2023 | Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis | Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis: A Randomised Controlled Trial: The NORSEMAN Study | Multiple Sclerosis;Progressive Multiple Sclerosis | Dietary Supplement: Nicotinamid riboside;Dietary Supplement: Placebo | Haukeland University Hospital | NULL | Not yet recruiting | 18 Years | 65 Years | All | 300 | Phase 2 | Norway |
| 3 | NCT05378100 (ClinicalTrials.gov) | January 1, 2023 | 12/5/2022 | Ketamine for Multiple Sclerosis Fatigue | Low-Dose Ketamine Infusion for the Treatment of Multiple Sclerosis Fatigue (INKLING-MS) | Multiple Sclerosis Fatigue | Drug: Ketamine;Drug: Midazolam | Johns Hopkins University | United States Department of Defense | Recruiting | 18 Years | 65 Years | All | 110 | Phase 2 | United States |
| 4 | EUCTR2022-003170-23-FI (EUCTR) | 20/12/2022 | 30/09/2022 | Hydroxychloroquine in progressive MS | Prospective, randomized, double-blind, placebo-controlled, single-center comparative trial evaluating oral hydroxychloroquine 200 mg BID for reducing microglial activation in the brain of patients with progressive multiple sclerosis (MS) | Progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Oxiklorin Product Name: Oxiklorin INN or Proposed INN: Hydroxychloroquine sulfate | Varsinais-Suomen sairaanhoitopiirin kuntayhtymä | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Finland | ||
| 5 | NCT05630547 (ClinicalTrials.gov) | December 19, 2022 | 7/11/2022 | A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis | A Phase 2 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effect of SAR443820 on Serum Neurofilament Levels in Participants With Multiple Sclerosis, Followed by an Open-label Long-term Extension Period | Multiple Sclerosis | Drug: SAR443820;Other: Placebo | Sanofi | NULL | Recruiting | 18 Years | 60 Years | All | 168 | Phase 2 | Belgium;Canada;China;France;Italy;Poland;Spain |
| 6 | NCT05418010 (ClinicalTrials.gov) | December 1, 2022 | 17/2/2022 | Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS) | AttackMS: Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation | Multiple Sclerosis;Clinically Isolated Syndrome of Demyelination | Drug: Tysabri Injectable Product;Drug: Placebo | Queen Mary University of London | Biogen;UCL Queen Square Institute of Neurology;Moorfields Eye Hospital NHS Foundation Trust;Barts & The London NHS Trust | Recruiting | 18 Years | 45 Years | All | 40 | Phase 2 | United Kingdom |
| 7 | NCT05551598 (ClinicalTrials.gov) | November 15, 2022 | 20/9/2022 | Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Randomized, Double-blind, Placebo-controlled Phase ? Clinical Study to Evaluate the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Drug: Mitoxantrone Hydrochloride Liposome Injection | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | NULL | Not yet recruiting | 18 Years | 60 Years | All | 45 | Phase 2 | NULL |
| 8 | NCT05092191 (ClinicalTrials.gov) | November 10, 2022 | 1/9/2021 | Cannabis as a Complementary Treatment in Multiple Sclerosis | Efficacy of Cannabinoids to the Current Standard Treatments on Symptom Relief in Persons With Multiple Sclerosis: Randomized Controlled Trial | Multiple Sclerosis | Drug: Cannabis oil vs placebo | Centre hospitalier de l'Université de Montréal (CHUM) | Canadian Institutes of Health Research (CIHR);Multiple Sclerosis Society of Canada | Recruiting | 21 Years | N/A | All | 250 | Phase 2 | Canada |
| 9 | NCT05403138 (ClinicalTrials.gov) | November 1, 2022 | 30/5/2022 | Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders | A Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders (NMOSD) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder;NMO Spectrum Disorder | Drug: Daratumumab;Drug: Placebo | Tianjin Medical University General Hospital | NULL | Recruiting | 18 Years | N/A | All | 72 | Phase 2/Phase 3 | China |
| 10 | NCT04880577 (ClinicalTrials.gov) | September 15, 2022 | 30/4/2021 | Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis | Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Fatigue | Drug: TENOFOVIR ALAFENAMIDE FUMARATE 25 Mg ORAL TABLET [VEMLIDY];Drug: Placebo | Massachusetts General Hospital | Gilead Sciences | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 11 | NCT05549258 (ClinicalTrials.gov) | August 25, 2022 | 22/7/2022 | Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder | An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder | Drug: Inebilizumab | Horizon Therapeutics Ireland DAC | NULL | Recruiting | 2 Years | 17 Years | All | 15 | Phase 2 | United States;Argentina;Brazil;Canada;France;Poland;Serbia;Spain;Sweden;United Kingdom |
| 12 | NCT05496894 (ClinicalTrials.gov) | August 2022 | 28/7/2022 | A Study of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis | A Phase ? Study to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection for Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Mitoxantrone Hydrochloride Liposome Injection | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | NULL | Withdrawn | 18 Years | 55 Years | All | 0 | Phase 2 | China |
| 13 | EUCTR2022-000049-34-ES (EUCTR) | 21/07/2022 | 22/07/2022 | Phase 2 study of SAR443820 in participants with multiple sclerosis (MS) | A Phase 2 double blind, randomized, placebo controlled study evaluating the effect of SAR443820 on serum neurofilament levels in participants with multiple sclerosis, followed by an open label long-term extension period | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR443820 INN or Proposed INN: SAR443820 Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489 | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 2 | France;United States;Czechia;Canada;Belgium;Poland;Spain;Germany;Italy;China | ||
| 14 | EUCTR2018-001896-19-DE (EUCTR) | 06/07/2022 | 05/04/2022 | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838-RC INN or Proposed INN: Vidofludimus calcium | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 2 | Poland;Ukraine;Romania;Bulgaria;Germany | ||
| 15 | NCT05346354 (ClinicalTrials.gov) | June 23, 2022 | 20/4/2022 | Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD | A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of Ravulizumab in Children and Adolescents With Aquaporin-4 Antibody Positive (AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Drug: Ravulizumab | Alexion Pharmaceuticals | NULL | Recruiting | 2 Years | 17 Years | All | 12 | Phase 2/Phase 3 | United States;Japan;Korea, Republic of;Spain |
| 16 | NCT05062083 (ClinicalTrials.gov) | June 7, 2022 | 29/9/2021 | PET Imaging of Cyclooxygenase-2 in Multiple Sclerosis | PET Imaging of Cyclooxygenases in Multiple Sclerosis | Multiple Sclerosis | Drug: 11C-MCI;Drug: 11C-PS13 | National Institute of Mental Health (NIMH) | University of Maryland | Recruiting | 18 Years | 99 Years | All | 16 | Phase 2 | United States |
| 17 | EUCTR2021-006075-42-ES (EUCTR) | 17/05/2022 | 24/02/2022 | Clinical study testing the efficacy and safety of Ravulizumab in pediatric patients with NMOSD | A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of Ravulizumab in Children and Adolescents With Aquaporin-4 antibody Positive (AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 2/3 Efficacy and Safety Study of Ravulizumab in Pediatric Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: ULTOMIRIS® Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2;Phase 3 | United States;France;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 18 | NCT05356858 (ClinicalTrials.gov) | May 7, 2022 | 26/4/2022 | An Open Label Study of the Effects and Safety of Zanubrutinib in NMOSDs Adult Patients | An Open Label Trial Evaluating the Efficacy and Safety of Bruton's Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Adult Patients With Neuromyelitis Optical Spectrum Disorders (NMOSDs) | Neuromyelitis Optica | Drug: zanubrutinib | Xuanwu Hospital, Beijing | NULL | Recruiting | 18 Years | 75 Years | All | 20 | Phase 2 | China |
| 19 | NCT05269628 (ClinicalTrials.gov) | March 25, 2022 | 13/2/2022 | Mechanisms of Cannabidiol in Persons With MS: the Role of Sleep and Pain Phenotype | Mechanisms of Cannabidiol (CBD) in Persons With Multiple Sclerosis (MS): the Role of Sleep and Pain Phenotype | Multiple Sclerosis;Sleep;Pain | Drug: Cannabidiol (CBD);Drug: Tetrahydrocannabinol (THC);Drug: Placebo CBD;Drug: Placebo THC | Tiffany J. Braley, MD, MS | National Center for Complementary and Integrative Health (NCCIH) | Recruiting | 18 Years | 65 Years | All | 166 | Phase 2 | United States |
| 20 | EUCTR2021-003772-14-HR (EUCTR) | 11/03/2022 | 14/03/2022 | A Study to Evaluate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis | A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TOINVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Serbia;Egypt;Czechia;Slovenia;Slovakia;Morocco;Kenya;Croatia;Norway;Japan | ||
| 21 | NCT05131828 (ClinicalTrials.gov) | March 8, 2022 | 12/11/2021 | CCMR Two: A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial of the Ability of the Combination of Metformin and Clemastine to Promote Remyelination in People With Relapsing-remitting Multiple Sclerosis Already on Disease-modifying Therapy | CCMR Two: A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial of the Ability of the Combination of Metformin and Clemastine to Promote Remyelination in People With Relapsing-remitting Multiple Sclerosis Already on Disease-modifying Therapy | Multiple Sclerosis | Drug: Metformin and clemastine in combination;Drug: Placebo | Cambridge University Hospitals NHS Foundation Trust | University of Cambridge | Recruiting | 25 Years | 50 Years | All | 50 | Phase 2 | United Kingdom |
| 22 | EUCTR2021-000048-23-DE (EUCTR) | 03/03/2022 | 07/10/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;United States;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
| 23 | NCT05119569 (ClinicalTrials.gov) | March 1, 2022 | 29/10/2021 | A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS) | A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Fenebrutinib;Drug: Placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 109 | Phase 2 | United States;Bosnia and Herzegovina;Croatia;Czechia;Serbia;Slovakia |
| 24 | EUCTR2021-000048-23-NL (EUCTR) | 10/02/2022 | 12/10/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 25 | NCT05298670 (ClinicalTrials.gov) | February 1, 2022 | 17/3/2022 | Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients | Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients | Multiple Sclerosis | Drug: MetFORMIN 1000 Mg Oral Tablet;Drug: Interferon beta-1a | German University in Cairo | NULL | Recruiting | 18 Years | 50 Years | All | 80 | Phase 2 | Egypt |
| 26 | NCT04764383 (ClinicalTrials.gov) | January 1, 2022 | 18/2/2021 | Histaminergic Basis of Fatigue in Multiple Sclerosis | Histaminergic Basis of Fatigue in Multiple Sclerosis | Multiple Sclerosis | Drug: L-Histidine;Drug: Placebo;Drug: Lodosyn | University of Miami | NULL | Withdrawn | 18 Years | 60 Years | All | 0 | Phase 2 | United States |
| 27 | EUCTR2021-000048-23-RO (EUCTR) | 27/12/2021 | 29/04/2022 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Netherlands;Germany;Moldova, Republic of | ||
| 28 | NCT05116540 (ClinicalTrials.gov) | November 24, 2021 | 27/10/2021 | Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis | A Randomized, Double-Blind, Single-Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: HB-adMSCs;Drug: Placebo | Hope Biosciences Stem Cell Research Foundation | NULL | Recruiting | 18 Years | 75 Years | All | 24 | Phase 2 | United States |
| 29 | EUCTR2021-003772-14-CZ (EUCTR) | 18/11/2021 | 27/08/2021 | A Study to Evaluate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis | A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TOINVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Other descriptive name: GDC-0853 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | Serbia;Egypt;Czechia;Czech Republic;Slovenia;Slovakia;Morocco;Kenya;Croatia;Norway;Japan | ||
| 30 | NCT04815967 (ClinicalTrials.gov) | November 16, 2021 | 11/2/2021 | Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity | Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC in Treatment of Adult Upper Limb Spasticity and Open-Label Extension, Multiple-Treatment Safety Study of MYOBLOC | Spasticity;Cerebrovascular Accident;Multiple Sclerosis;Traumatic Brain Injury;Cervical Spinal Cord Injury;Cerebral Palsy | Drug: Phase 2; Low Dose MYOBLOC; High Dose MYOBLOC; Placebo;Drug: Phase 3; MYOBLOC | Supernus Pharmaceuticals, Inc. | Solstice Neurosciences | Active, not recruiting | 18 Years | 80 Years | All | 272 | Phase 2/Phase 3 | United States;Czechia |
| 31 | EUCTR2021-000048-23-PL (EUCTR) | 04/11/2021 | 12/08/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients withProgressive Multiple Sclerosis - CALLIPER study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;United States;Czechia;Canada;Poland;Ukraine;Romania;North Macedonia;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
| 32 | NCT05122559 (ClinicalTrials.gov) | November 2021 | 8/11/2021 | Neuroprotection With N-acetyl Cysteine for Patients With Progressive Multiple Sclerosis | Randomized Controlled Trial of N-acetyl Cysteine as a Neuroprotective Agent in Progressive Multiple Sclerosis | Multiple Sclerosis;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Secondary Progressive | Drug: N-acetyl cysteine;Drug: Placebo | Emmanuelle Waubant | United States Department of Defense | Not yet recruiting | 40 Years | 70 Years | All | 98 | Phase 2 | NULL |
| 33 | EUCTR2021-000048-23-BG (EUCTR) | 28/10/2021 | 28/09/2021 | Study to test IMU-838 in patients with progressive multiple sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study | Progressive forms of Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of | ||
| 34 | NCT04909502 (ClinicalTrials.gov) | October 19, 2021 | 14/5/2021 | Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis | A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 | Relapsing Forms of Multiple Sclerosis | Drug: EHP-101 25 mg OD;Drug: EHP-101 25 mg BID;Drug: EHP-101 50 mg OD;Drug: EHP-101 50 mg BID | Emerald Health Pharmaceuticals | NULL | Suspended | 18 Years | 55 Years | All | 50 | Phase 2 | United States;Australia |
| 35 | NCT05013463 (ClinicalTrials.gov) | October 1, 2021 | 16/8/2021 | Hydroxychloroquine and Indapamide in SPMS | Open-label, Single-center, Single-arm Futility Trial Evaluating the Combination of Oral Hydroxychloroquine 200mg BID and Indapamide 2.5mg OD for Reducing Progression of Disability in People With Secondary Progressive Multiple Sclerosis (SPMS) | Multiple Sclerosis, Secondary Progressive | Drug: Hydroxychloroquine Pill;Drug: Indapamide Pill | University of Calgary | NULL | Recruiting | 18 Years | 60 Years | All | 35 | Phase 2 | Canada |
| 36 | NCT04767698 (ClinicalTrials.gov) | October 1, 2021 | 18/2/2021 | Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis | Addition of Belimumab to B-cell Depletion to Produce Prolonged Remission of Relapsing-remitting Multiple Sclerosis Disease Activity | Multiple Sclerosis | Drug: Belimumab;Drug: Short-course Ocrelizumab;Drug: Continued Ocrelizumab | Johns Hopkins University | GlaxoSmithKline | Terminated | 18 Years | N/A | All | 3 | Phase 2 | United States |
| 37 | NCT05054140 (ClinicalTrials.gov) | September 30, 2021 | 2/9/2021 | Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: IMU-838;Drug: Placebo matching IMU-838 | Immunic AG | NULL | Recruiting | 18 Years | 65 Years | All | 450 | Phase 2 | United States;Bulgaria;Canada;Czechia;Germany;Moldova, Republic of;Netherlands;North Macedonia;Poland;Romania;Serbia;Ukraine |
| 38 | NCT04971005 (ClinicalTrials.gov) | August 27, 2021 | 12/8/2020 | Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial | A Randomised Controlled Trial to Compare Ocrelizumab or Alemtuzumab With Autologous Hematopoietic Stem Cell Transplantation (aHSCT) in High Inflammatory Multiple Sclerosis (COAST) | Relapsing-Remitting Multiple Sclerosis | Drug: Autologous Hematopoietic Stem Cell Transplantation;Drug: Ocrelizumab;Drug: Alemtuzumab | Universitätsklinikum Hamburg-Eppendorf | Neovii Biotech;Clinical Trial Center North (CTC North GmbH & Co. KG) | Recruiting | 18 Years | 55 Years | All | 50 | Phase 2 | Germany |
| 39 | NCT05000216 (ClinicalTrials.gov) | August 13, 2021 | 6/8/2021 | COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders | Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01) | Rheumatoid Arthritis (RA);Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis (MS);Systemic Sclerosis (SSc);Pediatric SLE;Juvenile Idiopathic Arthritis (JIA);Juvenile Dermatomyositis (JDM);Pediatric-Onset Multiple Sclerosis (POMS) | Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: Continue IS (MMF or MPA);Drug: Continue IS (MTX);Biological: Continue IS (B cell depletion therapy);Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03;Drug: Withhold IS (MMF or MPA);Drug: Withhold IS (MTX);Drug: Withhold IS (B cell depletion therapy);Biological: Moderna mRNA-1273, Bivalent;Biological: BNT162b2, Bivalent | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Recruiting | 2 Years | N/A | All | 2340 | Phase 2 | United States |
| 40 | EUCTR2021-001973-21-SE (EUCTR) | 09/07/2021 | 04/06/2021 | Extension of Study GNC-401 with temelimab in patients with Multiple Sclerosis under treatment with rituximab | A long-term extension of Study GNC-401 with temelimab in patients with Relapsing forms of Multiple Sclerosis (RMS) under treatment with rituximab - ProTEct-MS Extension | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: TEMELIMAB Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: TEMELIMAB Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: TEMELIMAB | GeNeuro Innovation SAS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Sweden | ||
| 41 | EUCTR2020-004785-19-DE (EUCTR) | 07/07/2021 | 17/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 42 | JPRN-jRCT2031220259 | 06/07/2021 | 09/08/2022 | A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Studyto Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety ofRavulizumab in Children and Adolescents With Aquaporin-4 Antibody Positive(AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Studyto Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety ofRavulizumab in Children and Adolescents With Aquaporin-4 Antibody Positive(AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) - Phase 2/3 Efficacy and Safety Study of Ravulizumab IV in Pediatric ParticipantsWith NMOSD | Neuromyelitis Optica Spectrum Disorder NMOSD | Drug: Ravulizumab Participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance treatment with ravulizumab on Day 15 and every 8 weeks (q8w) after or once every 4 weeks (q4w) depending on weight. During the Extension Period, participants will continue to receive weight- based maintenance doses of ravulizumab IV on Day 351 and q8w or q4w, depending on weight. | Wuebbenhorst Hiroaki | NULL | Recruiting | >= 2age old | < 18age old | Both | 12 | Phase 2-3 | US;Spain;Japan |
| 43 | NCT04079088 (ClinicalTrials.gov) | June 30, 2021 | 3/9/2019 | Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) | A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Placebo;Drug: BIIB061;Biological: Interferon-beta1;Drug: Glatiramer acetate | Biogen | NULL | Not yet recruiting | 18 Years | 55 Years | All | 300 | Phase 2 | NULL |
| 44 | NCT04695080 (ClinicalTrials.gov) | June 25, 2021 | 6/11/2020 | ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis | ChariotMS - A National (UK) Phase IIb, Multi-centre, Randomised, Double-blind, Placebo Controlled (1:1) Efficacy Trial With Cost-utility Analysis of Cladribine Tablets (3.5mg/kg Over Two Years) in People With Advanced Multiple Sclerosis. Is Cladribine Superior to Placebo in Protecting Upper Limb Function? | Advanced Multiple Sclerosis;Progressive Multiple Sclerosis | Drug: Cladribine (MAVENCLAD®);Drug: Placebo | Queen Mary University of London | National Institute for Health Research, United Kingdom;Merck Serono Limited, UK;Multiple Sclerosis Society of Great Britain & Northern Ireland;National Multiple Sclerosis Society;Barts & The London NHS Trust | Recruiting | 18 Years | N/A | All | 200 | Phase 2/Phase 3 | United Kingdom |
| 45 | NCT04879628 (ClinicalTrials.gov) | June 7, 2021 | 6/5/2021 | Proof-of-concept Study for SAR441344 in Relapsing Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: SAR441344 IV;Drug: placebo IV;Drug: SAR441344 SC;Drug: placebo SC;Drug: MRI contrast-enhancing preparations | Sanofi | NULL | Active, not recruiting | 18 Years | 55 Years | All | 129 | Phase 2 | United States;Bulgaria;Canada;Czechia;France;Germany;Russian Federation;Spain;Turkey;Ukraine |
| 46 | NCT04625153 (ClinicalTrials.gov) | June 2, 2021 | 6/11/2020 | RC18 in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial | RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection in Patients With Relapsing Remitting Multiple Sclerosis:a Phase II Trial | Multiple Sclerosis, Relapsing-Remitting | Biological: RC18 160mg;Biological: RC18 240mg | RemeGen Co., Ltd. | NULL | Recruiting | 18 Years | 55 Years | All | 18 | Phase 2 | China |
| 47 | EUCTR2020-004785-19-CZ (EUCTR) | 01/06/2021 | 05/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Bulgaria;Russian Federation;Germany | ||
| 48 | NCT04979650 (ClinicalTrials.gov) | May 22, 2021 | 2/7/2021 | Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple Sclerosis | Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023 | Multiple Sclerosis, Relapsing-Remitting;Magnetic Resonance Imaging;Methylprednisolone | Drug: Methylprednisolone succinate;Drug: Normal saline | Mazandaran University of Medical Sciences | NULL | Enrolling by invitation | 18 Years | 55 Years | All | 104 | Phase 2 | Iran, Islamic Republic of |
| 49 | EUCTR2020-004785-19-BG (EUCTR) | 28/04/2021 | 09/03/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 50 | NCT04742400 (ClinicalTrials.gov) | April 15, 2021 | 5/2/2021 | Tolebrutinib, a Brain-penetrant Bruton s Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis | A Phase 2 Clinical Trial of Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis | Multiple Sclerosis | Drug: tolebrutinib 60mg;Drug: tolebrutinib 120mg | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Active, not recruiting | 18 Years | N/A | All | 11 | Phase 2 | United States |
| 51 | NCT04711148 (ClinicalTrials.gov) | March 1, 2021 | 8/1/2021 | A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity | Relapsing Remitting Multiple Sclerosis | Other: placebo;Drug: orelabrutinib | Beijing InnoCare Pharma Tech Co., Ltd. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 160 | Phase 2 | United States;China;Poland;Ukraine |
| 52 | NCT04670770 (ClinicalTrials.gov) | December 24, 2020 | 10/12/2020 | An Open Label Study of the Effects of SHR1459 in NMOSDs Patients | An Open Label Phase II Clinical Trial Evaluating the Efficacy and Safety of SHR1459 in Adult Patients With Neuromyelitis Optical Spectrum Disorders (NMOSDs) | Neuromyelitis Optica Spectrum Disorders | Drug: Drug - SHR1459 | Reistone Biopharma Company Limited | NULL | Active, not recruiting | 18 Years | 75 Years | All | 10 | Phase 2 | China |
| 53 | EUCTR2018-005038-39-GB (EUCTR) | 02/12/2020 | 29/09/2020 | A phase 2b study of Cladribine to halt deterioration in people with advanced multiple sclerosis | ChariotMS – A national (UK), multi-centre, randomised, double-blind, placebo-controlled (1:1) phase IIb efficacy trial with cost-utility analysis of cladribine tablets (3.5mg/kg over two years) in people with advanced multiple sclerosis (EDSS 6.5-8.5). Is cladribine superior to placebo in protecting upper limb function? - ChariotMS - Cladribine for people with advanced multiple sclerosis | Advanced Multiple Sclerosis (EDSS 6.5-8.5) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;Level: LLT;Classification code 10078558;Term: Multiple sclerosis plaque;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1;Classification code 10028246;Term: Multiple sclerosis aggravated;Classification code 10078559;Term: Multiple sclerosis brain lesion;System Organ Class: 10028245 - Multiple sclerosis MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10064137;Term: Progression of multiple sclerosis;Classification code 10053395;Term: Progressive multiple sclerosis;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;Level: PTClassification co;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: MAVENCLAD INN or Proposed INN: Cladribine | Queen Mary University of London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United Kingdom | ||
| 54 | NCT05283551 (ClinicalTrials.gov) | November 25, 2020 | 24/2/2022 | Famciclovir in Multiple Sclerosis | A Phase 2 Open Label Clinical Trial to Determine the Effect of Famciclovir on Epstein-Barr Virus Activity as Measured by EBV Shedding in Saliva of Patients With Multiple Sclerosis. | Multiple Sclerosis | Drug: Famciclovir | Queen Mary University of London | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United Kingdom |
| 55 | EUCTR2019-001967-58-FR (EUCTR) | 20/11/2020 | 27/05/2020 | Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dapirolizumab Pegol Product Code: BIIB133 INN or Proposed INN: DAPIROLIZUMAB PEGOL Trade Name: Ocrevus Product Name: OCREVUS INN or Proposed INN: OCRELIZUMAB Other descriptive name: OCRELIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 2 | United States;Serbia;France;Spain;Poland;Belgium;Germany;Switzerland;Italy | ||
| 56 | EUCTR2019-001967-58-PL (EUCTR) | 26/10/2020 | 25/06/2020 | Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dapirolizumab Pegol Product Code: BIIB133 INN or Proposed INN: DAPIROLIZUMAB PEGOL Trade Name: Ocrevus Product Name: OCREVUS INN or Proposed INN: OCRELIZUMAB Other descriptive name: OCRELIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Serbia;France;Spain;Belgium;Poland;Germany;Switzerland;Italy | ||
| 57 | NCT04626921 (ClinicalTrials.gov) | October 22, 2020 | 30/10/2020 | A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis | VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: CNM-Au8 | Clene Nanomedicine | George Clinical | Active, not recruiting | 18 Years | 55 Years | All | 150 | Phase 2/Phase 3 | Australia;Canada;United States |
| 58 | EUCTR2019-001829-26-DE (EUCTR) | 19/10/2020 | 08/01/2020 | A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Soliris Product Name: Soliris Product Code: Soliris INN or Proposed INN: ECULIZUMAB Other descriptive name: h5G1.1-mAb | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2;Phase 3 | United States;Canada;Spain;Germany;Italy;Japan;Korea, Republic of | ||
| 59 | EUCTR2017-003008-30-GB (EUCTR) | 01/07/2020 | 17/05/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A double-blind, randomised, placebo-controlled single-site study of high dose simvastatin treatment for secondary progressive multiple sclerosis: impact on vascular perfusion and oxidative damage - MS-OPT Version 1.3 dated 23/05/18 | Multiple Sclerosis (Secondary Progressive) MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets Product Code: Not applicable INN or Proposed INN: Simvastatin | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | ||
| 60 | EUCTR2019-001829-26-IT (EUCTR) | 19/06/2020 | 22/01/2021 | A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD). | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder. - NA | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML) Product Name: Soliris Product Code: [Soliris] INN or Proposed INN: ECULIZUMAB Trade Name: MENVEO Product Name: MENVEO Product Code: [NA] Other descriptive name: N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197 Trade Name: Bexsero Product Name: Bexsero Product Code: [NA] Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN Trade Name: Hiberix Product Name: Hiberix Product Code: [NA] Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) Trade Name: Prevenar 13 Product Name: Prevenar 13 Product Code: [NA] Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2;Phase 3 | United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 61 | EUCTR2019-004822-15-SE (EUCTR) | 18/05/2020 | 17/01/2020 | A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple Sclerosis | A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients with Relapsing Forms of Multiple Sclerosis (RMS) - ProTEct-MS | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab | GeNeuro Innovation SAS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Sweden | ||
| 62 | EUCTR2018-000620-34-DE (EUCTR) | 06/05/2020 | 08/11/2019 | Imatinib treatment for Multiple Sclerosis (MS) Relapses | Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS | Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: IMATINIB MESILATE INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Department of Clinical Neuroscience, Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Germany;Sweden | ||
| 63 | EUCTR2019-003127-38-NL (EUCTR) | 09/04/2020 | 09/04/2020 | Research on the effect of add-on high dosage simvastatin treatment on progression in MS patients treated with ocrelizumab and natalizumab. | Efficacy of add-on high dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial. - SIMSON trial | Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Simvastatin INN or Proposed INN: SIMVASTATIN Other descriptive name: Simvastatine | VUmc Neurology Department | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Netherlands | ||
| 64 | EUCTR2016-001166-29-DE (EUCTR) | 18/03/2020 | 12/08/2019 | A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) | A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) - COAST | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Lemtrada Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: ALEMTUZUMAB Trade Name: Ocrevus Product Name: ocrelizumab INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB Product Name: autologous hematopoietic stem cells Product Code: aHSC | University Medical Centre Hamburg-Eppendorf | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 65 | NCT02149706 (ClinicalTrials.gov) | March 9, 2020 | 24/5/2014 | A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis | A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination | Multiple Sclerosis | Biological: NeuroVax;Biological: IFA Incomplete Freund's Adjuvant | Immune Response BioPharma, Inc. | cro | Not yet recruiting | 18 Years | 70 Years | All | 150 | Phase 2 | United States |
| 66 | NCT02057159 (ClinicalTrials.gov) | March 9, 2020 | 4/2/2014 | A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis | A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis | Secondary Progress Multiple Sclerosis;Multiple Sclerosis | Biological: NeuroVax;Biological: IFA Placebo | Immune Response BioPharma, Inc. | cro | Recruiting | 18 Years | 50 Years | All | 200 | Phase 2/Phase 3 | United States |
| 67 | EUCTR2016-002667-34-PL (EUCTR) | 06/03/2020 | 14/11/2019 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | AN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-remitting multiple sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Poland;Italy | ||
| 68 | NCT04155424 (ClinicalTrials.gov) | January 14, 2020 | 5/11/2019 | A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Drug: Eculizumab | Alexion Pharmaceuticals | NULL | Recruiting | 2 Years | 17 Years | All | 12 | Phase 2/Phase 3 | United States;Canada;Germany;Italy;Japan;Korea, Republic of;Spain |
| 69 | NCT04075266 (ClinicalTrials.gov) | January 9, 2020 | 14/8/2019 | A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis | An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 10 Years | 18 Years | All | 36 | Phase 2 | United States;Italy;Poland |
| 70 | EUCTR2019-002566-13-NL (EUCTR) | 19/12/2019 | 29/10/2019 | Personalizing the treatment with natalizumab in patients with multiple sclerosis | Personalized extended interval dosing of natalizumab in relapsing remitting multiple sclerosis - NEXT-MS | Relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: natalizumab | Amsterdam University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 71 | NCT03993171 (ClinicalTrials.gov) | December 19, 2019 | 31/5/2019 | 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis. | A Phase 2, Open-Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: gold nanocrystals | Clene Nanomedicine | University of Texas Southwestern Medical Center | Recruiting | 18 Years | 55 Years | All | 30 | Phase 2 | United States |
| 72 | EUCTR2019-001829-26-ES (EUCTR) | 18/12/2019 | 06/11/2019 | A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Soliris INN or Proposed INN: ECULIZUMAB Other descriptive name: h5G1.1-mAb | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 73 | EUCTR2018-001511-73-HU (EUCTR) | 18/12/2019 | 08/11/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 74 | EUCTR2018-003008-38-HR (EUCTR) | 10/12/2019 | 17/01/2020 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany | ||
| 75 | NCT04211740 (ClinicalTrials.gov) | December 6, 2019 | 17/12/2019 | Phase II Clinical Trial of OCH-NCNP1 | Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Secondary Progressive | Drug: OCH-NCNP1;Drug: Placebo | National Center of Neurology and Psychiatry, Japan | NULL | Active, not recruiting | 20 Years | 65 Years | All | 30 | Phase 2 | Japan |
| 76 | EUCTR2018-004731-76-ES (EUCTR) | 19/11/2019 | 12/04/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis | Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 77 | EUCTR2019-003001-94-SK (EUCTR) | 06/11/2019 | 13/09/2019 | Use of GLP-1 analogs in the treatment of multiple sclerosis | Use of GLP-1 analogs in the treatment of multiple sclerosis - MSGLP | Our hypothesis is that patients with MS have a disorder of energy metabolism in neurons and glial cells of the CNS, contributing to the development and progression of demyelinating foci and neurodegeneration, and manifested by insulin resistance in both peripheral tissues and the CNS. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere. Product Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere | Lekárska fakulta UK Bratislava | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Slovakia | ||
| 78 | NCT03829566 (ClinicalTrials.gov) | November 2019 | 1/2/2019 | Autologous Transplant To End NMO Spectrum Disorder | Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica;Devic's Disease;NMO Spectrum Disorder | Drug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2/Phase 3 | United States |
| 79 | NCT03910738 (ClinicalTrials.gov) | October 29, 2019 | 1/4/2019 | TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis | TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection;Drug: Placebo 4 mL Solution for Injection;Procedure: MRI;Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities;Behavioral: Assessment of disability | University Hospital, Strasbourg, France | Bayer;Fédération Hospitalo-Universitaire NEUROGENYCS | Recruiting | 18 Years | 55 Years | Male | 40 | Phase 2 | France |
| 80 | EUCTR2017-001362-25-NL (EUCTR) | 30/09/2019 | 10/09/2019 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Thymoglobuline® Product Name: Thymoglobuline® INN or Proposed INN: ANTITHYMOCYTE IMMUNOGLOBULIN Other descriptive name: ANTITHYMOCYTE IMMUNOGLOBULIN Trade Name: Lemtrada INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB Trade Name: Mavenclad Product Name: Cladribine INN or Proposed INN: CLADRIBINE Trade Name: Ocrevus Product Name: Ocrelizumab INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Denmark;Netherlands | ||
| 81 | EUCTR2017-001224-22-IT (EUCTR) | 24/09/2019 | 20/01/2021 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: N/A Product Name: Opicinumab Product Code: [BIIB033] INN or Proposed INN: Opicinumab | BIOGEN IDEC RESEARCH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Sweden;United States;Czechia;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands | ||
| 82 | NCT03996291 (ClinicalTrials.gov) | September 23, 2019 | 20/6/2019 | Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis | Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Tolebrutinib | Sanofi | NULL | Active, not recruiting | 18 Years | 55 Years | All | 125 | Phase 2 | United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Spain;Ukraine |
| 83 | NCT04002934 (ClinicalTrials.gov) | September 10, 2019 | 25/6/2019 | Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis | A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Delayed-Start Trial to Assess the Efficacy, Safety, and Tolerability of Bazedoxifene Acetate (BZA) as a Remyelinating Agent in Patients With Multiple Sclerosis | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Bazedoxifene Acetate | Riley Bove, MD | NULL | Recruiting | 40 Years | 65 Years | Female | 50 | Phase 2 | United States |
| 84 | EUCTR2016-002667-34-IT (EUCTR) | 03/09/2019 | 20/01/2022 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | AN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY,TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSINGREMITTINGMULTIPLE SCLEROSIS - A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizum | Relapsing-remitting multiple sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: [RO4964913/F07-01] INN or Proposed INN: Ocrelizumab Other descriptive name: na | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Poland;Italy | ||
| 85 | EUCTR2019-000169-19-GB (EUCTR) | 03/09/2019 | 05/06/2019 | Clinical trial to determine the effect of Famciclovir on Epstein Barr virus levels in the saliva of patients with Multiple Sclerosis. | Clinical trial to determine the effect of Famciclovir on Epstein-Barr virus activity as measured by EBV shedding in saliva of patients with Multiple Sclerosis. - Famciclovir in Multiple Sclerosis | Epstein Barr virus infection in people with multiple sclerosis. MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10014077;Term: EBV infection;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Virus Diseases [C02] | Trade Name: Famciclovir Product Name: Famciclovir INN or Proposed INN: Famciclovir Other descriptive name: 2-(2-(2-Amino-9H-purin-9-yl)ethyl)-1,3-propanediol diacetate ester | Queen Mary University London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United Kingdom | ||
| 86 | EUCTR2019-001960-31-FI (EUCTR) | 27/08/2019 | 11/07/2019 | Effect of cladribine treatment on microglial activation in the CNS | Effect of cladribine treatment on microglial activation in the CNS | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad | Turku PET centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland | ||
| 87 | EUCTR2018-001511-73-ES (EUCTR) | 21/08/2019 | 04/07/2019 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | ||
| 88 | EUCTR2019-001505-24-NO (EUCTR) | 25/07/2019 | 28/05/2019 | A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple Sclerosis | Norwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS | Relapsing Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rituximab konsentrat til infusjonsvaeske oppløsning 10 mg/ml Product Name: Rituximab Trade Name: Mavenclad tabletter 10 mg Product Name: Cladribine | Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Norway | ||
| 89 | EUCTR2018-004731-76-CZ (EUCTR) | 12/07/2019 | 25/02/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis | Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 2 | France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 90 | NCT03774407 (ClinicalTrials.gov) | June 20, 2019 | 5/12/2018 | Vaginal Estriol in Multiple Sclerosis | Dual Benefits of Vaginal Estriol: Improved Urogenital Health and Re-myelination in Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis;Neurogenic Bladder | Drug: vaginal estriol | Texas Tech University Health Sciences Center | NULL | Completed | 40 Years | 65 Years | Female | 21 | Phase 2/Phase 3 | United States |
| 91 | EUCTR2017-004703-51-GB (EUCTR) | 18/06/2019 | 15/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 92 | NCT03888924 (ClinicalTrials.gov) | June 17, 2019 | 4/9/2018 | Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS) | Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS) | Multiple Sclerosis | Drug: Bacille Calmette-Guerin vaccine;Drug: Placebo | S. Andrea Hospital | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | Italy |
| 93 | EUCTR2018-004731-76-NL (EUCTR) | 11/06/2019 | 15/04/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis | Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 2 | France;United States;Czechia;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 94 | NCT04056897 (ClinicalTrials.gov) | June 7, 2019 | 12/8/2019 | Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis | International Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: BCD-132, 125 mg;Drug: Teriflunomide;Drug: Placebo;Biological: BCD-132, 500 mg | Biocad | NULL | Active, not recruiting | 18 Years | 60 Years | All | 270 | Phase 2 | Russian Federation |
| 95 | EUCTR2018-003008-38-HU (EUCTR) | 30/05/2019 | 08/04/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Germany;Tunisia | ||
| 96 | EUCTR2018-003927-12-NL (EUCTR) | 24/05/2019 | 23/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis | Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 97 | NCT03896217 (ClinicalTrials.gov) | May 16, 2019 | 26/10/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A Double-blind, Randomised, Placebo-controlled Single-site Study of High Dose Simvastatin Treatment for Secondary Progressive Multiple Sclerosis: Impact on Vascular Perfusion and Oxidative Damage | Secondary Progressive Multiple Sclerosis | Drug: Simvastatin | University College, London | MS Society | Recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | United Kingdom |
| 98 | EUCTR2017-004703-51-HR (EUCTR) | 06/05/2019 | 03/06/2019 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 99 | EUCTR2018-003927-12-ES (EUCTR) | 26/04/2019 | 22/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis | Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 100 | EUCTR2018-004731-76-SK (EUCTR) | 18/04/2019 | 25/02/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 101 | EUCTR2018-004731-76-EE (EUCTR) | 04/04/2019 | 14/03/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis | Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 2 | France;United States;Czechia;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 102 | EUCTR2018-003008-38-ES (EUCTR) | 02/04/2019 | 17/05/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Kuwait;Tunisia;Germany | ||
| 103 | NCT03889639 (ClinicalTrials.gov) | March 29, 2019 | 1/3/2019 | Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis | A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: SAR442168;Drug: Placebo;Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 130 | Phase 2 | United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Slovakia;Spain;Ukraine;Sweden |
| 104 | EUCTR2018-003927-12-SK (EUCTR) | 18/03/2019 | 23/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 105 | NCT03799718 (ClinicalTrials.gov) | March 13, 2019 | 7/1/2019 | Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS | A Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MS | Multiple Sclerosis, Chronic Progressive | Biological: NurOwn (MSC-NTF cells) | Brainstorm-Cell Therapeutics | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 2 | United States |
| 106 | EUCTR2018-003927-12-EE (EUCTR) | 11/03/2019 | 28/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis | Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 107 | EUCTR2018-002145-11-FR (EUCTR) | 08/03/2019 | 31/10/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - NOVA | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 108 | EUCTR2018-003927-12-SE (EUCTR) | 06/03/2019 | 11/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis | Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 INN or Proposed INN: Not available Other descriptive name: PRN2246 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 109 | EUCTR2018-000516-22-HU (EUCTR) | 04/03/2019 | 02/01/2019 | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of | ||
| 110 | NCT03737812 (ClinicalTrials.gov) | February 27, 2019 | 6/11/2018 | A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: elezanumab;Drug: placebo | AbbVie | NULL | Completed | 18 Years | 65 Years | All | 123 | Phase 2 | United States;Canada |
| 111 | EUCTR2017-001294-16-DE (EUCTR) | 18/02/2019 | 07/11/2018 | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) INN or Proposed INN: Not available Other descriptive name: Diroximel fumarate Trade Name: Tecfidera® 120 mg Product Name: Tecfidera® 120 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240 mg Product Name: Tecfidera® 240 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Germany | ||
| 112 | EUCTR2017-004703-51-ES (EUCTR) | 31/01/2019 | 25/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 113 | NCT03846219 (ClinicalTrials.gov) | January 28, 2019 | 21/1/2019 | MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS) | Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial Assessing the Effect of IMU-838 on Disease Activity, as Measured by Magnetic Resonance Imaging (MRI), as Well as Safety and Tolerability in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Drug: IMU-838 (30 mg/day);Drug: IMU-838 (45 mg/day);Drug: Placebo | Immunic AG | NULL | Active, not recruiting | 18 Years | 55 Years | All | 210 | Phase 2 | Bulgaria;Poland;Romania;Ukraine |
| 114 | EUCTR2017-004702-17-PL (EUCTR) | 25/01/2019 | 17/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 115 | EUCTR2017-004703-51-FR (EUCTR) | 18/01/2019 | 22/10/2018 | Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis | An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2233 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 116 | EUCTR2018-000516-22-EE (EUCTR) | 14/01/2019 | 17/12/2018 | Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3- Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TECFIDERA Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Estonia;Taiwan;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of | ||
| 117 | EUCTR2018-002145-11-ES (EUCTR) | 02/01/2019 | 05/11/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom | ||
| 118 | EUCTR2018-001896-19-BG (EUCTR) | 17/12/2018 | 11/10/2018 | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) | Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Product Name: VIDOFLUDIMUS CALCIUM Product Code: IMU-838-RC INN or Proposed INN: Vidofludimus calcium | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 2 | Poland;Ukraine;Romania;Bulgaria | ||
| 119 | EUCTR2017-004702-17-ES (EUCTR) | 12/12/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 284 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 120 | JPRN-jRCTs051180080 | 12/12/2018 | 27/02/2019 | Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients | Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients - An open treatment trial of NMO with MMF | Neuromyelitis optica | Mycophenolate mofetil treatment for 1 year | Sekiguchi Kenji | NULL | Complete | >= 20age old | < 80age old | Both | 10 | Phase 2 | Japan |
| 121 | NCT03737851 (ClinicalTrials.gov) | December 11, 2018 | 6/11/2018 | A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: elezanumab;Drug: placebo | AbbVie | NULL | Completed | 18 Years | 65 Years | All | 208 | Phase 2 | United States;Canada |
| 122 | EUCTR2018-002315-98-DK (EUCTR) | 06/12/2018 | 09/07/2018 | The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury. | The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI | Central neuropathic pain and spasticity MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10077975;Term: Central neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol capsule 5 mg Product Code: N/A INN or Proposed INN: Cannabidiol Other descriptive name: CBD Product Name: Dronabinol capsule 2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC INN or Proposed INN: Cannabidiol Other descriptive name: CBD | Aarhus Universitetshospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Denmark | ||
| 123 | EUCTR2017-004702-17-BG (EUCTR) | 03/12/2018 | 23/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 124 | NCT03944447 (ClinicalTrials.gov) | December 1, 2018 | 3/5/2019 | Outcomes Mandate National Integration With Cannabis as Medicine | Outcomes Mandate National Integration With Cannabis as Medicine | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus | Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler | OMNI Medical Services, LLC | OMNI Medical Services Inc | Recruiting | 7 Years | N/A | All | 200000 | Phase 2 | United States |
| 125 | EUCTR2017-004702-17-IT (EUCTR) | 07/11/2018 | 04/11/2020 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND | Multiple sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE Product Name: Formistin 10 mg Product Code: [Formistin 10 mg] Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [Tachipirina CPR 500mg] Other descriptive name: paracetamolo 500 mg Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Solumedrol IM 125mg/2ml Product Code: [Metilprednisolone] Other descriptive name: Metilprednisolone sodio succinato Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: Ofatumumab Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: OFATUMUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia | ||
| 126 | EUCTR2017-004702-17-LV (EUCTR) | 02/11/2018 | 03/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy | ||
| 127 | EUCTR2017-004702-17-LT (EUCTR) | 31/10/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 128 | EUCTR2017-004702-17-CZ (EUCTR) | 23/10/2018 | 16/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 129 | NCT03740295 (ClinicalTrials.gov) | October 5, 2018 | 5/10/2018 | Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis | Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: Coconut oil and epigallocatechin gallate;Other: Placebo | Fundación Universidad Católica de Valencia San Vicente Mártir | Valencian Institute of Neurorehabilitation Foundation | Completed | 19 Years | 65 Years | All | 60 | Phase 2 | Spain |
| 130 | NCT03674099 (ClinicalTrials.gov) | October 1, 2018 | 14/9/2018 | Imatinib for Multiple Sclerosis (MS) Relapses | Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study | Multiple Sclerosis | Drug: Imatinib Mesylate;Drug: Methylprednisolone | Tomas Olsson | The Swedish Research Council | Recruiting | 18 Years | 55 Years | All | 200 | Phase 2 | Denmark;Germany;Norway;Sweden |
| 131 | NCT03355365 (ClinicalTrials.gov) | September 21, 2018 | 14/11/2017 | Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis | Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally | Multiple Sclerosis | Biological: Intrathecal MSC-NP injection;Other: Intrathecal saline injection | Tisch Multiple Sclerosis Research Center of New York | NULL | Active, not recruiting | 18 Years | 65 Years | All | 50 | Phase 2 | United States |
| 132 | EUCTR2017-004702-17-EE (EUCTR) | 17/09/2018 | 28/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 133 | NCT03560739 (ClinicalTrials.gov) | September 11, 2018 | 15/5/2018 | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | Multiple Sclerosis | Combination Product: ofatumumab with PRF;Combination Product: ofatumumab with AI | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 284 | Phase 2 | United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain |
| 134 | EUCTR2017-004158-40-FR (EUCTR) | 11/09/2018 | 04/07/2018 | NA | A Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714 - INN-MS | Patients with Relapsing MS or primary progressive MS MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrevus INN or Proposed INN: ocrelizumab Other descriptive name: ocrelizumab | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 71 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 135 | EUCTR2017-004702-17-AT (EUCTR) | 01/09/2018 | 10/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 136 | EUCTR2014-000253-36-NL (EUCTR) | 30/08/2018 | 16/04/2018 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2;Phase 3 | Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;India;Peru;Australia;South Africa;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;New Zealand;Japan | ||
| 137 | EUCTR2018-001292-21-FR (EUCTR) | 27/07/2018 | 05/06/2018 | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years | Secondary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AVONEX Product Name: BETAFERON Product Code: L03 AB 08 Product Name: EXTAVIA Product Name: REBIF Product Name: PLEDIGRY Product Name: COPAXONE Product Name: AUBAGIO Product Name: TECFIDERA Product Name: GILENYA Product Name: TYSABRI Product Name: IMUREL Product Name: NOVATREX Product Name: CELLCEPT Product Name: ENDOXAN | CHU de Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 138 | EUCTR2017-004886-29-FR (EUCTR) | 05/07/2018 | 17/05/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 139 | EUCTR2018-000721-31-SE (EUCTR) | 04/07/2018 | 24/04/2018 | A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis. | RItuximab Long-Term DOSE Trial in Multiple Sclerosis – RIDOSE-MSA randomized trial of long-term dosage of rituximab in multiple sclerosisThe RIDOSE-MS trial is a multi-centre trial of long-term treatment with rituximab in MS, randomised between two different dosing regimens. Population: Patients with RRMS that has completed the RIFUND-MS trial in either the rituximab or DMF arm. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Intervention: Treatment with rituximab (Mabthera®) 500 mg every six months. Both the previous rituximab and DMF arms from the RIFUND trial will be treated with rituximab in the RIDOSE trial.Control: After one year of treatment in RIDOSE-MS, patients will be randomised 1:1 to either continue with 500 mg every 6 months or 500 mg every 12 months and continue on this treatment schedule for another 3 years.Outcome: Primary outcome will be the proportion of patients remaining with no evidence of disease activity (NEDA) -3 over the randomised period of 3 years. As secondary endpoints progression of disability, brain atrophy, cognitive function and level of serum Neurofilament-Light will be evaluated. In addition, Patient-related outcome scales measuring fatigue, work ability and treatment satisfaction will be analysed. - RIDOSE-MS | Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB | Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Sweden | ||
| 140 | NCT03000127 (ClinicalTrials.gov) | July 1, 2018 | 17/12/2016 | Testosterone for Fatigue in Men With MS | A Pilot Trial of Testosterone Treatment for Fatigue in Men With Multiple Sclerosis | Multiple Sclerosis | Drug: AndroGel 1 % Topical Gel;Drug: Placebos | University of California, Los Angeles | Washington University School of Medicine | Withdrawn | 18 Years | 60 Years | Male | 0 | Phase 2 | United States |
| 141 | NCT03161028 (ClinicalTrials.gov) | July 1, 2018 | 18/5/2017 | Lipoic Acid for Progressive Multiple Sclerosis (MS) | Lipoic Acid for the Treatment of Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Lipoic acid;Drug: Placebo | VA Office of Research and Development | NULL | Active, not recruiting | 18 Years | 70 Years | All | 115 | Phase 2 | United States;Canada |
| 142 | EUCTR2017-004886-29-ES (EUCTR) | 22/05/2018 | 09/04/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial | A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL | Multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 143 | EUCTR2018-000620-34-SE (EUCTR) | 24/04/2018 | 14/03/2018 | Imatinib treatment for Multiple Sclerosis (MS) Relapses | Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study - Imatinib MS | Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where there are radiological and/or cerebrospinal fluid signs consistent with MS), which display an acute relapse MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10028247;Term: Multiple sclerosis like syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: IMATINIB MESILATE Trade Name: Solu-Medrol Product Name: Solu-Medrol INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Department of Clinical Neuroscience, Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Sweden | ||
| 144 | EUCTR2017-000426-35-AT (EUCTR) | 17/04/2018 | 12/03/2018 | The efficacy of treatment of patients with multiple sclerosis, a chronic, inflammatory, autoimmune, disease that leads to neurologic deficits and aggravates with flairs, with low doses of rituximab, an antibody directed against the CD20 epitope on B Lymphocytes, specific cells of the immune system contributing to the progression of the disease - a pilot trial | Efficacy of Rituximab at low doses in Multiple Sclerosis – A prospective, randomized, double-blind, active controlled, pilo trial - Low-dose Rituximab in MS | Relapse Remitting Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB | Medical University of Vienna - Department of Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | Austria | ||
| 145 | EUCTR2016-004719-10-HR (EUCTR) | 27/03/2018 | 12/04/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 146 | NCT03387046 (ClinicalTrials.gov) | March 26, 2018 | 22/12/2017 | A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS) | Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE) | Multiple Sclerosis, Relapsing-Remitting | Dietary Supplement: D-aspartate;Drug: Placebo;Biological: IFN beta-1a;Drug: Methylprednisolone | Merck KGaA, Darmstadt, Germany | NULL | Terminated | 18 Years | 55 Years | All | 7 | Phase 2 | Italy;Germany |
| 147 | NCT03249714 (ClinicalTrials.gov) | March 15, 2018 | 11/8/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Drug: Ofatumumab;Drug: Matching placebo of ofatumumab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 64 | Phase 2 | Japan;Russian Federation |
| 148 | JPRN-JapicCTI-173711 | 15/3/2018 | 14/09/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Intervention name : Ofatumumab INN of the intervention : - Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks | Novartis Pharma K.K. | NULL | complete | 18 | 55 | BOTH | 30 | Phase 2 | Japan, Russia |
| 149 | NCT03005119 (ClinicalTrials.gov) | March 1, 2018 | 25/12/2016 | Evaluation of the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in MS Patients With Spasticity-related Symptoms | A Phase II, Double-blind, Randomized, Placebocontrolled, Parallel-group, Single-center Study to Evaluate the Safety, Tolerability, and Efficacy of Orally Administered PTL201 in Multiple Sclerosis (MS) Patients With Spasticity-related Symptoms | Multiple Sclerosis | Drug: PTL201;Drug: Placebo Oral Capsule | PhytoTech Therapeutics, Ltd. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 70 | Phase 2 | Israel |
| 150 | EUCTR2017-001224-22-PL (EUCTR) | 08/02/2018 | 15/11/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 151 | EUCTR2017-001224-22-BE (EUCTR) | 02/02/2018 | 08/09/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 152 | EUCTR2017-001224-22-DE (EUCTR) | 23/01/2018 | 28/07/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czechia;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 153 | EUCTR2017-001224-22-NL (EUCTR) | 11/01/2018 | 12/09/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden | ||
| 154 | EUCTR2017-001224-22-GB (EUCTR) | 28/12/2017 | 12/07/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) - EV Substance Code SUB118957 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 155 | EUCTR2017-001224-22-CZ (EUCTR) | 19/12/2017 | 14/08/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 156 | NCT03362294 (ClinicalTrials.gov) | December 11, 2017 | 15/11/2017 | Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS | A Prospective, Multicenter, Two Arms, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 25 mg or 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS) | Primary Progressive Multiple Sclerosis | Drug: GA Depot 40mg once monthly;Drug: GA Depot 25mg once monthly | Mapi Pharma Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 30 | Phase 2 | Israel;Moldova, Republic of |
| 157 | EUCTR2017-001176-31-FR (EUCTR) | 07/12/2017 | 16/01/2018 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 158 | NCT03315923 (ClinicalTrials.gov) | December 1, 2017 | 17/10/2017 | Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients | Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate | Secondary Progressive Multiple Sclerosis | Drug: Rituximab;Drug: Glatiramer Acetate | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 55 Years | All | 84 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 159 | EUCTR2016-003100-30-DE (EUCTR) | 29/11/2017 | 07/03/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 160 | EUCTR2017-001224-22-ES (EUCTR) | 24/11/2017 | 18/09/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 161 | EUCTR2016-004935-18-IT (EUCTR) | 20/11/2017 | 22/01/2021 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 | GENEURO SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;Czechia;Estonia;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Poland;Croatia;Bulgaria;Germany | ||
| 162 | NCT03222973 (ClinicalTrials.gov) | November 14, 2017 | 17/7/2017 | Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies | Multiple Sclerosis | Drug: BIIB033 (opicinumab);Drug: Placebo | Biogen | NULL | Terminated | 18 Years | 58 Years | All | 263 | Phase 2 | Netherlands;Poland;Spain;Switzerland;United Kingdom;United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy |
| 163 | EUCTR2017-001176-31-GB (EUCTR) | 06/11/2017 | 21/07/2017 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 164 | NCT03350633 (ClinicalTrials.gov) | November 1, 2017 | 10/11/2017 | Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders | Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial | Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica | Drug: Tocilizumab Injection;Drug: Azathioprine | Tianjin Medical University General Hospital | NULL | Completed | 18 Years | N/A | All | 118 | Phase 2/Phase 3 | China |
| 165 | EUCTR2017-001224-22-HU (EUCTR) | 31/10/2017 | 01/09/2017 | Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicinumab Product Code: BIIB033 INN or Proposed INN: Opicinumab Other descriptive name: BIIB033 (ANTI-LINGO) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 166 | EUCTR2017-002838-23-ES (EUCTR) | 27/10/2017 | 21/07/2017 | Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) | Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) | patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ORY2001 Product Code: ORY2001 INN or Proposed INN: Not yet requested Other descriptive name: PHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR | Oryzon Genomics S. A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Spain | ||
| 167 | EUCTR2016-003100-30-NO (EUCTR) | 12/10/2017 | 12/04/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden | ||
| 168 | EUCTR2016-003100-30-PT (EUCTR) | 28/08/2017 | 04/05/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 169 | NCT03183869 (ClinicalTrials.gov) | August 24, 2017 | 9/5/2017 | Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients | Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients | Autoimmune Diseases;Relapsing Multiple Sclerosis | Drug: Fecal microbiota | Lawson Health Research Institute | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 2 | Canada |
| 170 | EUCTR2017-001253-13-BE (EUCTR) | 23/08/2017 | 11/07/2017 | Does decresaed perfusion of the brain play a role in the reduced function of axons and the clinical disability and fatigue in patients with multiple sclerosis ? | Does cerebral hypoperfusion play a role in reduced axonal metabolism and clinical disability in patients with multiple sclerosis ? - ROCHIMS (Role of Cerebral Hypoperfusion In Multiple Sclerosis) | Patients suffering relapsing- remitting multiple sclerosis will be investigated in this study, with an EDSS score less or equal to 4.0. Patients must be older than 18 years old. There must not be any clinical evidence of an MS relpase within the 3 months prior to inclusion.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Tracleer | UZ Brussel | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Belgium | ||
| 171 | NCT02744222 (ClinicalTrials.gov) | August 10, 2017 | 3/4/2016 | Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple Sclerosis | An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 µg and 240 µg, Versus Avonex® (Biogen Idec Ltd., UK) in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: BCD-054 180 mcg;Biological: Avonex®;Biological: BCD-054 240 mcg;Other: Placebo | Biocad | NULL | Completed | 18 Years | 60 Years | All | 399 | Phase 2/Phase 3 | Russian Federation |
| 172 | EUCTR2016-004935-18-PL (EUCTR) | 26/06/2017 | 07/04/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Spain;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 173 | EUCTR2016-004935-18-HR (EUCTR) | 26/06/2017 | 12/09/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 174 | EUCTR2016-004935-18-BG (EUCTR) | 22/06/2017 | 11/04/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Estonia;Czech Republic;Poland;Spain;Ukraine;Serbia;Hungary;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 175 | EUCTR2016-004935-18-DE (EUCTR) | 19/06/2017 | 16/02/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 176 | NCT03239860 (ClinicalTrials.gov) | June 6, 2017 | 12/7/2017 | Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GNbAC1 Monoclonal Antibody | GeNeuro SA | Les Laboratoires Servier;Worldwide Clinical Trials;Institut de Recherches Internationales Servier | Terminated | 18 Years | 55 Years | All | 220 | Phase 2 | Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 177 | NCT03381170 (ClinicalTrials.gov) | June 1, 2017 | 18/12/2017 | An Extension of the TG1101-RMS201 Trial | An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Biological: Ublituximab | TG Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 48 | Phase 2 | United States |
| 178 | EUCTR2016-004935-18-CZ (EUCTR) | 01/06/2017 | 20/02/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 179 | EUCTR2016-001448-21-PL (EUCTR) | 09/05/2017 | 13/01/2017 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Czech Republic;Slovakia;Spain;Poland;Ukraine;Turkey;Croatia;Russian Federation;Bulgaria;United Kingdom | ||
| 180 | EUCTR2016-004935-18-HU (EUCTR) | 12/04/2017 | 02/02/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;Estonia;Czech Republic;Hungary;Spain;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 181 | EUCTR2016-003100-30-IT (EUCTR) | 11/04/2017 | 14/05/2019 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) - na | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada INN or Proposed INN: alemtuzumab | GENZYME CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 182 | EUCTR2016-001448-21-BG (EUCTR) | 11/04/2017 | 14/02/2017 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria | ||
| 183 | EUCTR2016-003100-30-ES (EUCTR) | 04/04/2017 | 22/02/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 184 | EUCTR2014-000253-36-GR (EUCTR) | 31/03/2017 | 30/01/2017 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 19.1;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: NA | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 185 | EUCTR2016-004935-18-ES (EUCTR) | 24/03/2017 | 10/03/2017 | A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple Sclerosis | A Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS | Multiple Sclerosis (MS) MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not Available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy | ||
| 186 | NCT03091400 (ClinicalTrials.gov) | March 16, 2017 | 16/3/2017 | Recall Enhancement Through Treatment With Atomoxetine in MS (RETAIN-MS) | Phase Two Randomized Controlled Crossover Trial of Atomoxetine to Treat Memory Impairment Due to Multiple Sclerosis | Memory Disorders;Multiple Sclerosis | Drug: Atomoxetine;Drug: Placebo | Icahn School of Medicine at Mount Sinai | NULL | Completed | 21 Years | 60 Years | All | 11 | Phase 2 | United States |
| 187 | NCT02975349 (ClinicalTrials.gov) | March 7, 2017 | 23/11/2016 | A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing-remitting Multiple Sclerosis | Drug: M2951;Drug: Placebo;Drug: Tecfidera | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Active, not recruiting | 18 Years | 65 Years | All | 267 | Phase 2 | Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States |
| 188 | EUCTR2016-001448-21-SK (EUCTR) | 16/02/2017 | 25/10/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Bulgaria | ||
| 189 | EUCTR2016-001448-21-CZ (EUCTR) | 06/02/2017 | 01/11/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | ||
| 190 | EUCTR2014-000253-36-HU (EUCTR) | 24/01/2017 | 23/11/2016 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 191 | EUCTR2016-001448-21-ES (EUCTR) | 05/01/2017 | 26/10/2016 | A Study of Efficacy and Safety of M2951 in Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: M2951 Product Code: M2951 INN or Proposed INN: M2951 Other descriptive name: M2951 Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera Product Name: Tecfidera INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom | ||
| 192 | NCT03172741 (ClinicalTrials.gov) | January 2017 | 25/5/2017 | The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis | The Effects of Different Medical Marijuana Strains on Motor and Cognitive Function in People With Multiple Sclerosis | Multiple Sclerosis | Drug: Medical Marijuana;Drug: Placebo | Colorado State University | NULL | Withdrawn | 21 Years | 74 Years | All | 0 | Phase 2/Phase 3 | NULL |
| 193 | NCT02959658 (ClinicalTrials.gov) | December 2016 | 8/11/2016 | Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis | Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: Dimethyl Fumarate;Drug: Placebo Oral Capsule | Rigshospitalet, Denmark | Biogen | Active, not recruiting | 18 Years | 65 Years | All | 54 | Phase 2 | Denmark |
| 194 | EUCTR2016-002180-33-PL (EUCTR) | 16/11/2016 | 14/07/2016 | Multiple sclerosis therapy with transdermal myelin peptide stimulation. | Multiple sclerosis therapy with transdermal myelin peptide stimulation. | relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: Avonex INN or Proposed INN: Interferon beta 1-A Other descriptive name: INTERFERON BETA-1A | Centrum Neurologii Krzysztof Selmaj | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 2 | Poland | ||
| 195 | EUCTR2015-003471-30-NL (EUCTR) | 02/11/2016 | 26/04/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Czech Republic;Taiwan;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 196 | NCT02913157 (ClinicalTrials.gov) | November 2016 | 20/9/2016 | Hydroxychloroquine in Primary Progressive Multiple Sclerosis | Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS) | Multiple Sclerosis, Primary Progressive | Drug: Hydroxychloroquine | University of Calgary | NULL | Completed | 18 Years | 65 Years | All | 35 | Phase 2 | Canada |
| 197 | NCT02784210 (ClinicalTrials.gov) | October 5, 2016 | 26/5/2016 | Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques | The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study | Multiple Sclerosis | Drug: Methylprednisolone;Drug: Prednisone | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 198 | NCT02804594 (ClinicalTrials.gov) | October 1, 2016 | 3/6/2016 | A Study of Oxidative Pathways in MS Fatigue | A Phase 2 Randomized, Placebo- Controlled, Parallel Group, Double Blinded Single Center Study on Effect of N-acetyl Cysteine Compared to Placebo on Fatigue in Patients With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis;Fatigue | Drug: N-acetyl cysteine;Drug: Placebo | University of California, San Francisco | NULL | Completed | 18 Years | 75 Years | All | 15 | Phase 2 | United States |
| 199 | NCT01649050 (ClinicalTrials.gov) | October 2016 | 6/7/2012 | Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis | A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis | Muscle Spasticity Due to Multiple Sclerosis | Drug: BGG492;Drug: Placebo | Novartis Pharmaceuticals | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2 | Germany;Russian Federation |
| 200 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 201 | EUCTR2015-003471-30-PL (EUCTR) | 23/09/2016 | 15/07/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Czech Republic;Taiwan;Canada;Malaysia;Poland;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 202 | EUCTR2016-000283-41-DK (EUCTR) | 12/09/2016 | 29/06/2016 | Treatment with dimethyl fumarate in patients with primary progressive multiple sclerosis | Dimethyl fumarate treatment of primary progressive multiple sclerosis - FUMAPMS | Primary progressive multiple sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tecfidera Product Name: dimethyl fumarate Product Code: dimethyl fumarate INN or Proposed INN: dimethyl fumarate Other descriptive name: DIMETHYL FUMARATE | Finn Sellebjerg | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 2 | Denmark | ||
| 203 | EUCTR2015-004059-29-CZ (EUCTR) | 18/08/2016 | 09/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 204 | NCT02466074 (ClinicalTrials.gov) | August 17, 2016 | 3/6/2015 | Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis | Augmenting Cerebral Blood Flow to Treat Established Multiple Sclerosis | Multiple Sclerosis | Drug: Acetazolamide;Drug: Placebo | The University of Texas Health Science Center, Houston | NULL | Terminated | 18 Years | 55 Years | All | 6 | Phase 2 | United States |
| 205 | EUCTR2015-004059-29-IT (EUCTR) | 09/08/2016 | 27/02/2018 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | GENEURO SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | |||
| 206 | EUCTR2015-000507-44-LT (EUCTR) | 11/07/2016 | 16/05/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 207 | EUCTR2015-004059-29-DE (EUCTR) | 04/07/2016 | 16/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 208 | EUCTR2015-004059-29-BG (EUCTR) | 30/06/2016 | 08/04/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 209 | EUCTR2015-003282-29-DE (EUCTR) | 17/06/2016 | 11/02/2016 | Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Poland;Belgium;Lebanon;Turkey;Bulgaria;Latvia;Kuwait;Germany | ||
| 210 | NCT02424396 (ClinicalTrials.gov) | June 13, 2016 | 20/4/2015 | Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis | Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis. Multicentric Randomized Study | Relapsing Remitting Multiple Sclerosis | Drug: IL2;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Fondation ARSEP/AFM | Completed | 18 Years | 65 Years | All | 30 | Phase 2 | France |
| 211 | EUCTR2016-000464-42-DE (EUCTR) | 13/06/2016 | 11/04/2016 | The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab | A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse | Relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab Other descriptive name: ALEMTUZUMAB | Genzyme GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany | ||
| 212 | NCT03150966 (ClinicalTrials.gov) | June 8, 2016 | 6/5/2017 | The Immunomodulatory Effects of Oral Nanocurcumin in Multiple Sclerosis Patients | The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Nanocurcumin;Drug: Placebo | Tabriz University of Medical Sciences | NULL | Completed | 18 Years | 65 Years | All | 41 | Phase 2 | Iran, Islamic Republic of |
| 213 | NCT02609607 (ClinicalTrials.gov) | June 2016 | 16/11/2015 | Treating Anorectal Dysfunction in MS | Treating Anorectal Dysfunction Associated With Multiple Sclerosis | Constipation;Fecal Incontinence;Multiple Sclerosis | Drug: Bisacodyl;Other: Placebo | David Levinthal | Consortium of Multiple Sclerosis Centers | Terminated | 18 Years | 80 Years | All | 11 | Phase 2 | United States |
| 214 | EUCTR2015-003471-30-CZ (EUCTR) | 27/05/2016 | 16/03/2016 | A study looking at DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination caused by spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: DYSPORT® Product Name: DYSPORT® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 408 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Czech Republic;Canada;Poland;Malaysia;Romania;Turkey;Netherlands;Italy;Korea, Republic of | ||
| 215 | NCT02676739 (ClinicalTrials.gov) | May 20, 2016 | 3/2/2016 | Adderall XR and Cognitive Impairment in MS | A Double-blind Placebo Controlled Study of Mixed-amphetamine Salts, Extended Release (Adderall XR) for Cognitive Impairment in MS | Multiple Sclerosis | Drug: Adderall XR | Sarah Morrow | NULL | Recruiting | 18 Years | 59 Years | All | 180 | Phase 2/Phase 3 | Canada |
| 216 | EUCTR2015-004059-29-EE (EUCTR) | 16/05/2016 | 22/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Poland;Croatia;Bulgaria;Germany;Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary | ||
| 217 | EUCTR2015-004059-29-PL (EUCTR) | 15/05/2016 | 21/03/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 218 | EUCTR2015-004059-29-HU (EUCTR) | 04/05/2016 | 08/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Czech Republic;Poland;Croatia;Bulgaria;Germany | ||
| 219 | EUCTR2015-001202-34-IT (EUCTR) | 04/05/2016 | 08/06/2021 | A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity, | A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity. Correlation between [11C]-PK-11195 or [18F]-NAF PET (Positron Emission Tomography) and high field MRI (Magnetic Resonance Imaging): a synergistic effect by using a double-technique approach. - A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier | Multiple Sclerosis MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Na18F Product Code: Na18F Product Name: [11C]-PK-11195 Product Code: [11C]-PK-11195 | AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 2 | Italy | ||
| 220 | EUCTR2015-004059-29-HR (EUCTR) | 29/04/2016 | 06/07/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Serbia;Estonia;Spain;Ukraine;Croatia;Bulgaria;Germany | ||
| 221 | EUCTR2015-004059-29-ES (EUCTR) | 20/04/2016 | 17/02/2016 | Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis | An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS | Multiple Sclerosis (MS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available Product Name: GNbAC1 Product Code: GNbAC1 INN or Proposed INN: Not available | GeNeuro SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany | ||
| 222 | NCT02782858 (ClinicalTrials.gov) | April 2016 | 23/5/2016 | Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS | An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GNbAC1;Drug: Placebo | GeNeuro SA | Les Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical Trials | Completed | 18 Years | 55 Years | All | 270 | Phase 2 | Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 223 | EUCTR2015-000507-44-BE (EUCTR) | 31/03/2016 | 08/03/2016 | A study to investigate DYSPORT® for the treatment of subjects with loss of bladder control and involuntary urination as a result of spinal cord injury or multiple sclerosis | A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10046543;Term: Urinary incontinence;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Not possible to specify | Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Trade Name: Dysport® Product Name: Dysport® INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Ukraine;Lithuania;Russian Federation;Chile;Israel;Colombia;United Kingdom;France;Mexico;Argentina;Belgium;Brazil;Peru;Germany;New Zealand | ||
| 224 | NCT02738775 (ClinicalTrials.gov) | March 18, 2016 | 10/4/2016 | Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple Sclerosis | A Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis. | Multiple Sclerosis | Biological: Ublituximab;Drug: Placebo | TG Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 48 | Phase 2 | United States |
| 225 | EUCTR2015-001973-42-BG (EUCTR) | 11/02/2016 | 02/02/2016 | Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: Dimethyl Fumarate | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait | ||
| 226 | NCT02710214 (ClinicalTrials.gov) | February 2016 | 11/3/2016 | A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis | Effect of a Tissue Selective Estrogen Complex on Menopausal Symptoms in Women With MS: A Pilot Trial. | Menopause;Multiple Sclerosis | Drug: Tissue Selective Estrogen Complex;Drug: Placebo | University of California, San Francisco | National Multiple Sclerosis Society | Completed | 18 Years | 62 Years | Female | 24 | Phase 2 | United States |
| 227 | EUCTR2015-000922-12-FR (EUCTR) | 28/01/2016 | 26/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 228 | EUCTR2015-000922-12-IE (EUCTR) | 22/12/2015 | 09/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 229 | NCT02011451 (ClinicalTrials.gov) | December 2015 | 10/12/2013 | Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis | Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis | Multiple Sclerosis | Drug: 95% Pure ECGC capsules 200mg;Drug: Placebo Comparator: | Louisiana State University Health Sciences Center in New Orleans | National Multiple Sclerosis Society | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 2 | United States |
| 230 | NCT02893111 (ClinicalTrials.gov) | December 2015 | 27/8/2016 | Efficacy and Safety of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder | Single-center, Open Label Trial of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder | Drug: Bortezomib | Tianjin Medical University General Hospital | NULL | Completed | 18 Years | N/A | Female | 5 | Phase 2 | China |
| 231 | NCT02545959 (ClinicalTrials.gov) | November 30, 2015 | 7/9/2015 | Intrathecal Rituximab in Progressive Multiple Sclerosis | Intrathecal Rituximab in Progressive Multiple Sclerosis | Multiple Sclerosis, Chronic Progressive;Nervous System Diseases | Drug: Rituximab IT;Drug: methylprednisolone IV;Drug: Rituximab IV | Centre Hospitalier de PAU | University Hospital, Bordeaux | Completed | 45 Years | N/A | All | 10 | Phase 2 | France |
| 232 | EUCTR2012-003735-32-GR (EUCTR) | 19/11/2015 | 06/08/2015 | Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Relapsing-remitting multiple sclerosis (RR MS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| 233 | EUCTR2012-000540-10-LT (EUCTR) | 21/10/2015 | 17/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 234 | EUCTR2014-005003-24-DE (EUCTR) | 12/10/2015 | 25/02/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 235 | EUCTR2015-002500-91-HU (EUCTR) | 12/10/2015 | 26/08/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 236 | EUCTR2012-000540-10-GR (EUCTR) | 02/10/2015 | 05/11/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 237 | NCT02410200 (ClinicalTrials.gov) | September 30, 2015 | 2/4/2015 | Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate | Biogen | NULL | Completed | 10 Years | 17 Years | All | 22 | Phase 2 | United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic |
| 238 | EUCTR2012-000540-10-LV (EUCTR) | 25/09/2015 | 14/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 239 | EUCTR2014-005003-24-PL (EUCTR) | 25/09/2015 | 12/06/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 240 | EUCTR2012-000540-10-FI (EUCTR) | 23/09/2015 | 19/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 241 | EUCTR2014-005003-24-CZ (EUCTR) | 21/09/2015 | 02/03/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | United States;Lebanon;Turkey;Lithuania;Israel;Italy;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 242 | EUCTR2012-000540-10-CZ (EUCTR) | 15/09/2015 | 17/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 243 | NCT03002038 (ClinicalTrials.gov) | September 2015 | 21/12/2016 | Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients | Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica Spectrum Disorder | Drug: Azathioprine;Drug: Rituximab | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 50 Years | All | 86 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 244 | EUCTR2014-005493-11-FR (EUCTR) | 31/08/2015 | 15/03/2018 | Study the action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action in patients with Progressive Multiple Sclerosis. | Intrathecal Rituximab in Progressive Multiple Sclerosis - EFFRITE | Patients included in our study suffer from a progressive form of Multiple sclerosis and will be treated by intravenous and intrathecal rituximab, with intravenous methylprednisolone.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Méthylprednisolone Mylan Product Name: méthylprednisolone Trade Name: Mabthera Product Name: rituximab Trade Name: Mabthera Product Name: rituximab | Centre Hospitalier de Pau | NULL | Not Recruiting | Female: yes Male: yes | 12 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 245 | EUCTR2014-005003-24-BG (EUCTR) | 21/08/2015 | 13/05/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | United States;Lebanon;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 246 | NCT02686788 (ClinicalTrials.gov) | August 2015 | 14/10/2015 | TMP001 in Relapsing-remitting Multiple Sclerosis | TMP001 in Relapsing-remitting Multiple Sclerosis: A Multicentre Open, Baseline-controlled Phase IIa Clinical Trial | Remitting-Relapsing Multiple Sclerosis | Drug: TMP001 | Dr. Frank Behrens | SocraMetrics GmbH | Completed | 18 Years | 55 Years | All | 9 | Phase 2 | Germany |
| 247 | NCT02493049 (ClinicalTrials.gov) | August 2015 | 2/7/2015 | Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis (RRMS) | Randomized, Controlled Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Domperidone | University of Calgary | Alberta Innovates Health Solutions | Completed | 18 Years | 60 Years | All | 17 | Phase 2 | Canada |
| 248 | NCT02542787 (ClinicalTrials.gov) | August 2015 | 4/9/2015 | Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis | A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis | Spasticity in People With Multiple Sclerosis | Drug: VSN16R;Other: Placebo | Canbex Therapeutics Ltd | NULL | Completed | 18 Years | 70 Years | All | 160 | Phase 2 | United Kingdom |
| 249 | EUCTR2012-000540-10-FR (EUCTR) | 31/07/2015 | 03/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 250 | EUCTR2014-005003-24-BE (EUCTR) | 29/07/2015 | 30/06/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia | ||
| 251 | EUCTR2014-004483-38-DE (EUCTR) | 16/07/2015 | 28/04/2015 | TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial | TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial | Patients with defined diagnosis of relapsing-remitting multiple sclerosis and at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tarenflurbil Product Code: TMP001 INN or Proposed INN: Tarenflurbil Other descriptive name: FLURBIPROFEN | Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Germany | ||
| 252 | EUCTR2014-001643-20-SE (EUCTR) | 03/07/2015 | 19/01/2015 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Germany;Italy;Switzerland;Sweden;United States;Czech Republic;Mexico;Canada;Poland;Russian Federation | ||
| 253 | EUCTR2013-002660-17-DK (EUCTR) | 02/06/2015 | 16/04/2015 | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS | multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolmod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 281 | Phase 2 | Portugal;France;Canada;Finland;Poland;Spain;Denmark;Germany;Italy;United Kingdom;Switzerland | ||
| 254 | EUCTR2014-005003-24-LV (EUCTR) | 01/06/2015 | 19/02/2015 | A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis' | Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Latvia;Germany;Kuwait | ||
| 255 | NCT02239393 (ClinicalTrials.gov) | June 2015 | 10/9/2014 | Safety and Efficacy of Intravenous Autologous Mesenchymal Stem Cells for MS: a Phase 2 Proof of Concept Study | MEsenchymal Stem Cell Therapy for CAnadian MS Patients | Multiple Sclerosis | Biological: Mesenchymal Stem Cells | Ottawa Hospital Research Institute | NULL | Completed | 18 Years | 50 Years | All | 31 | Phase 2 | Canada |
| 256 | EUCTR2014-001579-30-NL (EUCTR) | 21/05/2015 | 26/11/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Spain;Poland;Ukraine;Russian Federation;Germany;Netherlands;United Kingdom;Italy | ||
| 257 | EUCTR2014-003265-19-PL (EUCTR) | 12/05/2015 | 26/02/2015 | Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839 | A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839 | Relapsing-remitting multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 258 | NCT02471222 (ClinicalTrials.gov) | May 2015 | 11/6/2015 | Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment | Walking Impairment;Multiple Sclerosis | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 60 | Phase 2 | United States |
| 259 | EUCTR2014-005548-17-FR (EUCTR) | 28/04/2015 | 03/06/2015 | TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY | TREATMENT OF PENDULAR NYSTAGMUS WITH GABAPENTIN AND MEMANTINE IN PATIENTS WITH MULTIPLE SCLEROSIS or OCULOPALATAL TREMOR:A CONTROLED OPEN-LABEL STUDY | PENDULAR NYSTAGMUS IN PATIENTS WITH MULTIPLE SCLEROSIS OR OCULOPALATAL TREMOR MedDRA version: 18.0;Level: PT;Classification code 10029864;Term: Nystagmus;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: NEURONTIN Product Name: Gabapentine Product Code: N03AX12 Other descriptive name: GABAPENTIN Trade Name: EBIXA Product Name: MEMANTINE Product Code: N06DX01 INN or Proposed INN: MEMANTINE | HOSPICES CIVILS DE LYON | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | France | |||
| 260 | EUCTR2013-001151-12-CZ (EUCTR) | 22/04/2015 | 19/09/2014 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Arab Emirates;Saudi Arabia;Thailand;Spain;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden;Taiwan;Hong Kong;Martinique | ||
| 261 | JPRN-UMIN000017217 | 2015/04/21 | 21/04/2015 | An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica | An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2 | Neuromyelitis optica | Rituximab intravenous infusion | Clinical Research Center, Utano National Hospital, National Hospital Organization | Zenyaku Kogyo Co., Ltd. | Complete: follow-up complete | 16years-old | 80years-old | Male and Female | 40 | Phase 2,3 | Japan |
| 262 | EUCTR2012-003735-32-SK (EUCTR) | 01/04/2015 | 09/04/2015 | Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| 263 | NCT02391961 (ClinicalTrials.gov) | April 1, 2015 | 3/3/2015 | Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis | Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis | Multiple Sclerosis;Internuclear Ophthalmoplegia;Fatigue | Drug: Dalfampridine;Drug: Placebo | VA Office of Research and Development | NULL | Completed | 18 Years | 65 Years | All | 23 | Phase 2 | United States |
| 264 | NCT02200770 (ClinicalTrials.gov) | April 1, 2015 | 16/7/2014 | N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | Drug: Inebilizumab;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | All | 231 | Phase 2/Phase 3 | United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;Mexico;Moldova, Republic of;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Turkey;China;Czech Republic;Greece;India;Netherlands;Portugal;Ukraine |
| 265 | NCT02939079 (ClinicalTrials.gov) | April 2015 | 14/10/2016 | Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients | Evaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-a , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod;Dietary Supplement: Fish Oil;Drug: Placebo (for Fish Oil) | Isfahan University of Medical Sciences | Shiraz University of Medical Sciences | Completed | 18 Years | 45 Years | All | 50 | Phase 2/Phase 3 | NULL |
| 266 | EUCTR2014-001579-30-DE (EUCTR) | 20/03/2015 | 11/11/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 267 | EUCTR2014-003145-99-GB (EUCTR) | 19/03/2015 | 19/01/2015 | A trial to determine bexarotene's safety and tolerability and it's ability to promote brain repair in patients with multiple sclerosis. | A randomised placebo-controlled study of the safety and tolerability of a retinoid-X receptor agonist's ability to promote remyelination in people with relapsing-remitting multiple sclerosis already on interferon-beta therapy: a phase 2a trial - CCMR One | Relapsing-remitting multiple sclerosis already on interferon-beta therapy MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targretin Product Name: Bexarotene INN or Proposed INN: Bexarotene | Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | ||
| 268 | NCT02097849 (ClinicalTrials.gov) | February 28, 2015 | 25/3/2014 | Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis. | An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis. | Relapsing Forms of Multiple Sclerosis | Drug: dimethyl fumarate;Biological: tetanus diphtheria toxoids vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent);Drug: non-pegylated interferon | Biogen | NULL | Completed | 18 Years | 55 Years | All | 71 | Phase 2 | United States |
| 269 | EUCTR2014-000253-36-DE (EUCTR) | 27/02/2015 | 30/09/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 270 | EUCTR2014-000253-36-ES (EUCTR) | 16/02/2015 | 22/12/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: NA | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2;Phase 3 | United States;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 271 | EUCTR2014-001643-20-DE (EUCTR) | 10/02/2015 | 18/08/2014 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 272 | EUCTR2014-000253-36-BG (EUCTR) | 04/02/2015 | 05/11/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 273 | NCT02308137 (ClinicalTrials.gov) | February 2015 | 2/12/2014 | Domperidone in Secondary Progressive Multiple Sclerosis (SPMS) | Open-label, Single-center, Single-arm Futility Trial Evaluating Oral Domperidone 10mg QID for Reducing Progression of Disability in Patients With Secondary Progressive Multiple Sclerosis (SPMS) | Multiple Sclerosis, Secondary Progressive | Drug: Domperidone | University of Calgary | Alberta Innovates Health Solutions | Completed | 18 Years | 60 Years | All | 64 | Phase 2 | Canada |
| 274 | NCT02638038 (ClinicalTrials.gov) | February 2015 | 16/12/2015 | This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for = 3 Years | A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing Remitting | Drug: INT131 | InteKrin Therapeutics, Inc. | NULL | Completed | 18 Years | 50 Years | All | 228 | Phase 2 | NULL |
| 275 | NCT02306811 (ClinicalTrials.gov) | February 2015 | 1/12/2014 | Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839 | A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839 | Relapsing-remitting Multiple Sclerosis | Drug: Vatelizumab | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 62 | Phase 2 | United States;Canada;Poland;Russian Federation |
| 276 | NCT02166021 (ClinicalTrials.gov) | January 29, 2015 | 20/5/2014 | Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis | Phase 2 Trial to Investigate the Clinical Efficacy & the Optimal Administration (Based on the Immunological, Clinical & Neuroradiological Effects) of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis | Multiple Sclerosis (MS) | Biological: Mesenchymal stem cells | Dimitrios Karussis | NULL | Completed | 18 Years | 65 Years | All | 48 | Phase 2 | Israel |
| 277 | EUCTR2014-001643-20-PL (EUCTR) | 23/01/2015 | 31/10/2014 | Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) | Nervous System Diseases MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: CHR-1103 / GBR500 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | United States;Czech Republic;Mexico;Canada;Poland;Russian Federation;Germany;Italy;Switzerland;Sweden | ||
| 278 | EUCTR2014-004412-11-GB (EUCTR) | 16/01/2015 | 19/11/2014 | The purpose of this study is to examine the safety and efficacy of VSN16R and the performance in treating spasticity (tightness, stiffness or pull of muscles) in patients with Multiple Sclerosis (MS). | A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: VSN16R 100mg Product Code: VSN16R INN or Proposed INN: VSN16R Other descriptive name: (R) 3-(5-Dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1- methylethyl) benzamide | Canbex Therapeutics Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 279 | NCT02284568 (ClinicalTrials.gov) | January 12, 2015 | 31/10/2014 | A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo | A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS) | Primary Progressive Multiple Sclerosis | Drug: Placebo;Drug: Laquinimod | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 25 Years | 55 Years | All | 374 | Phase 2 | United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 280 | EUCTR2013-002660-17-PT (EUCTR) | 02/01/2015 | 14/11/2014 | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS | multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolmod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 281 | Phase 2 | France;Portugal;Canada;Finland;Poland;Spain;Denmark;Germany;Italy;United Kingdom;Switzerland | ||
| 281 | EUCTR2014-000253-36-PL (EUCTR) | 30/12/2014 | 14/11/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 282 | EUCTR2014-001579-30-ES (EUCTR) | 22/12/2014 | 23/10/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 283 | NCT01910259 (ClinicalTrials.gov) | December 18, 2014 | 19/7/2013 | MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial | A Multi-arm Phase IIB Randomised, Double Blind Placebo-controlled Clinical Trial Comparing the Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis. | Secondary Progressive Multiple Sclerosis | Drug: Amiloride;Drug: Riluzole;Drug: Fluoxetine;Drug: Placebo | University College, London | Medical Research Council;National Institute for Health Research, United Kingdom;MS Society;University of Edinburgh;Queen Mary University of London;Keele University;University of Sheffield;University of Leeds;University of Warwick | Completed | 25 Years | 65 Years | All | 445 | Phase 2 | United Kingdom |
| 284 | EUCTR2014-000253-36-CZ (EUCTR) | 08/12/2014 | 14/08/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 285 | EUCTR2014-001579-30-IT (EUCTR) | 04/12/2014 | 19/09/2014 | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 286 | NCT02317263 (ClinicalTrials.gov) | December 2014 | 3/12/2014 | A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis | Multiple Sclerosis | Drug: testosterone;Drug: placebo gel | University of California, Los Angeles | NULL | Withdrawn | 18 Years | 60 Years | Male | 0 | Phase 2 | NULL | |
| 287 | NCT02142192 (ClinicalTrials.gov) | December 2014 | 16/5/2014 | Natalizumab Subcutaneous Immunogenicity and Safety Study | A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Terminated | 18 Years | 65 Years | Both | 2 | Phase 2 | Belgium;Denmark;Germany;Italy |
| 288 | EUCTR2014-001579-30-GB (EUCTR) | 27/11/2014 | 08/09/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as compared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 289 | EUCTR2014-000917-30-DE (EUCTR) | 25/11/2014 | 03/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Phase 2 | Belgium;Denmark;Germany;Italy | ||
| 290 | EUCTR2011-005677-23-EE (EUCTR) | 21/11/2014 | 22/10/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Not Recruiting | Female: yes Male: yes | 190 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 291 | EUCTR2013-002378-26-SE (EUCTR) | 13/11/2014 | 15/08/2013 | Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes | Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext | The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial. MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera® Product Name: Mabthera | Västerbottens Läns Landsting | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 2 | Sweden | ||
| 292 | EUCTR2014-000253-36-EE (EUCTR) | 24/10/2014 | 13/10/2014 | A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MEDI-551 Product Code: MEDI-551 INN or Proposed INN: Inebilizumab | MedImmune LLC | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand | ||
| 293 | EUCTR2014-000221-20-AT (EUCTR) | 23/10/2014 | 25/06/2014 | Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical Trial | Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical Trial | Clinically Isolated Syndrome and Relapsing-remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RNS60 Product Code: RNS60 | University Hospital Zürich | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Austria;Switzerland | ||
| 294 | EUCTR2012-002714-40-HR (EUCTR) | 17/10/2014 | 05/11/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1410 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Slovenia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 295 | NCT02096133 (ClinicalTrials.gov) | October 13, 2014 | 21/3/2014 | Vitamin D3 and the Stress-axis in MS | Regulation of the Stress-axis by Vitamin D3 in Subjects With Multiple Sclerosis; a Double-blinded, Randomized, Placebo-controlled Study | Multiple Sclerosis | Drug: Cholecalciferol;Other: Placebo comparator | Academic MS Center Limburg | NULL | Terminated | 18 Years | N/A | Female | 54 | Phase 2 | Netherlands |
| 296 | NCT02280096 (ClinicalTrials.gov) | October 2014 | 10/10/2014 | Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis | Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis. Randomized, Blinded, Placebo-controlled Clinical Trial. | Multiple Sclerosis | Drug: 4-aminopyridine;Drug: Placebo | Coordinación de Investigación en Salud, Mexico | NULL | Completed | 18 Years | 60 Years | All | 24 | Phase 2 | Mexico |
| 297 | NCT02104661 (ClinicalTrials.gov) | October 2014 | 1/4/2014 | Protective Role of Oxcarbazepine in Multiple Sclerosis | OxCarbazepine as a Neuroprotective Agent in MS: A Phase 2a Trial | Multiple Sclerosis | Drug: Oxcarbazepine;Drug: Placebo | Queen Mary University of London | National Multiple Sclerosis Society;Novartis Pharmaceuticals;Barts & The London NHS Trust;University College, London;Royal Free Hospital NHS Foundation Trust;Southend University Hospital;Basildon and Thurrock University Hospitals NHS Foundation Trust;St George's Healthcare NHS Trust;Barnet and Chase Farm Hospitals NHS Trust | Completed | 18 Years | 60 Years | All | 30 | Phase 2 | United Kingdom |
| 298 | NCT02228213 (ClinicalTrials.gov) | October 2014 | 21/8/2014 | Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis | A Phase 2B Randomised, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of MIS416 in the Treatment of Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Biological: MIS416;Drug: Saline | Innate Immunotherapeutics | INC Research | Completed | 18 Years | 70 Years | All | 93 | Phase 2 | Australia;New Zealand |
| 299 | NCT02286557 (ClinicalTrials.gov) | October 2014 | 16/10/2014 | Testing the Effects of Methylphenidate on Multiple Sclerosis | Testing the Effects of Methylphenidate on Cognitive Fatigue in Multiple Sclerosis: a Double-blind, Placebo-controlled, Randomized Clinical Trial | Fatigue in Multiple Sclerosis | Drug: Methelphenidate;Drug: Placebo | Kessler Foundation | NULL | Not yet recruiting | 18 Years | 65 Years | Both | 36 | Phase 2 | NULL |
| 300 | NCT02222948 (ClinicalTrials.gov) | September 2014 | 20/8/2014 | Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) | Relapsing-remitting Multiple Sclerosis | Drug: Vatelizumab;Drug: Placebo (for Vatelizumab) | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | 55 Years | Both | 112 | Phase 2 | United States;Canada;Poland;Russian Federation;Sweden |
| 301 | EUCTR2011-005677-23-GB (EUCTR) | 15/07/2014 | 12/03/2014 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 302 | EUCTR2013-004533-32-PL (EUCTR) | 04/07/2014 | 05/05/2014 | A Study that evaluates the efficacy and safety of BG00012 in patients with RRMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 202 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Taiwan;Poland;Japan;Korea, Republic of | ||
| 303 | NCT02727907 (ClinicalTrials.gov) | July 2014 | 29/5/2015 | Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis | International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: BCD-033 (interferon beta 1a);Drug: Rebif (interferon beta 1a);Drug: Placebo | Biocad | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 147 | Phase 2/Phase 3 | Russian Federation |
| 304 | EUCTR2013-002324-16-CZ (EUCTR) | 13/06/2014 | 08/01/2014 | Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis | A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Czech Republic;Poland;Ukraine;Russian Federation | ||
| 305 | EUCTR2013-002324-16-PL (EUCTR) | 04/06/2014 | 09/04/2014 | Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis | A randomized, partially blind, placebo-controlled, proof-of-concept study to assess the effect of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | United States;Czech Republic;Poland;Ukraine;Russian Federation | ||
| 306 | EUCTR2011-005249-12-ES (EUCTR) | 03/06/2014 | 01/04/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China | ||
| 307 | EUCTR2012-002714-40-SK (EUCTR) | 02/06/2014 | 12/03/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 308 | EUCTR2012-002714-40-GB (EUCTR) | 29/05/2014 | 28/02/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1265 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 309 | EUCTR2013-001151-12-FR (EUCTR) | 13/05/2014 | 25/09/2015 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing Neuromyelitis Optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 93 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 310 | EUCTR2013-001150-10-FR (EUCTR) | 13/05/2014 | 21/09/2015 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing neuromyelitis optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 93 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Arab Emirates;Taiwan;Hong Kong;Saudi Arabia;Spain;Chile;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 311 | JPRN-UMIN000013453 | 2014/05/10 | 18/03/2014 | A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody | A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody - RIN-1 | Neuromyelitis optica | Rituximab intravenous infusion Placebo | Clinical Research Center, NHO Utano National Hospital | Zenyaku Kogyo Co., Ltd. | Complete: follow-up complete | 16years-old | 80years-old | Male and Female | 40 | Phase 2,3 | Japan |
| 312 | EUCTR2013-002283-25-PL (EUCTR) | 18/04/2014 | 21/01/2014 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 313 | EUCTR2013-002660-17-IT (EUCTR) | 09/04/2014 | 17/02/2014 | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis | Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase II program in relapsing multiple sclerosis - ACROSS | multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolmod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Farma SpA | NULL | Not Recruiting | Female: yes Male: yes | 281 | Phase 2 | France;Portugal;Canada;Finland;Spain;Poland;Denmark;Germany;United Kingdom;Switzerland;Italy | ||
| 314 | EUCTR2012-005394-31-GB (EUCTR) | 01/04/2014 | 05/09/2014 | MS-SMART: A Trial of Efficacy (usefulness) of 3 Neuroprotective Drugs in SPMS | MS-SMART: A Multi-Arm Phase IIb Randomised, Double Blind Placebo-Controlled Clinical Trial Comparing The Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis - MS-SMART: Multiple Sclerosis Secondary Progressive Multi-Arm Randomisation Trial | Mutliple Sclerosis (Secondary Progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rilutek Product Name: Rilutek INN or Proposed INN: Riluzole Trade Name: Amiloride Product Name: Amiloride INN or Proposed INN: Amiloride Trade Name: Fluoxetine Product Name: Fluoxetine INN or Proposed INN: Fluoxetine hydrochloride | UCL | NULL | Not Recruiting | Female: yes Male: yes | 440 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 315 | EUCTR2013-002419-87-GB (EUCTR) | 18/03/2014 | 07/02/2014 | PROXIMUS (PRotective role of OXcabazepine In MUltiple Sclerosis) | Oxcarbazepine as a neuroprotective agent in MS: phase 2a trial - PROXIMUS - PRotective role of OXcabazepine In MUltiple Sclerosis | Multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Trileptal Product Name: Oxcarbazepine INN or Proposed INN: oxcarbazepine Other descriptive name: Trileptal | Queen Mary University London | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 316 | EUCTR2013-002283-25-GB (EUCTR) | 18/03/2014 | 09/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 317 | EUCTR2013-002283-25-GR (EUCTR) | 18/03/2014 | 01/11/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 318 | NCT01973491 (ClinicalTrials.gov) | February 28, 2014 | 23/10/2013 | ATX-MS-1467 in Multiple Sclerosis | An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and Its Effect on Immune Tolerance in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: ATX-MS-1467 | Merck KGaA | NULL | Completed | 18 Years | 65 Years | All | 37 | Phase 2 | Germany |
| 319 | EUCTR2013-002283-25-BG (EUCTR) | 07/02/2014 | 04/12/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 320 | NCT02166346 (ClinicalTrials.gov) | February 2014 | 16/6/2014 | Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch) | Double-Blind, Placebo-Controlled Crossover Trial on the Safety and Efficacy of Sustained-Release Dalfampridine in Transverse Myelitis (Re-Launch) | Transverse Myelitis;Neuromyelitis Optica;Idiopathic Transverse Myelitis;Myelitis NOS | Drug: Dalfampridine;Drug: Placebo | Johns Hopkins University | Acorda Therapeutics | Completed | 18 Years | 70 Years | All | 24 | Phase 2 | United States |
| 321 | EUCTR2013-002283-25-ES (EUCTR) | 31/01/2014 | 06/11/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 322 | NCT02040298 (ClinicalTrials.gov) | January 2014 | 10/1/2014 | Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis | A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Crossover Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Clemastine;Drug: Placebo | University of California, San Francisco | NULL | Completed | 18 Years | 60 Years | Both | 50 | Phase 2 | United States |
| 323 | EUCTR2013-002283-25-HR (EUCTR) | 27/12/2013 | 02/09/2014 | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Male and female patients between the ages of 18 and 60 years with a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: Plovamer acetate Other descriptive name: Plovamer acetate | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 324 | NCT02038049 (ClinicalTrials.gov) | December 20, 2013 | 14/1/2014 | A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis | A Randomized, Partially Blind, Placebo-controlled, Proof-of-concept Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity as Measured by Brain MRI Scans in Patients With Relapsing-remitting Multiple Sclerosis | Relapse Remitting Multiple Sclerosis | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 8 | Phase 2 | United States;Czechia;Ukraine;Czech Republic;Germany;Poland;Russian Federation |
| 325 | EUCTR2013-002283-25-CZ (EUCTR) | 18/12/2013 | 26/09/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 326 | EUCTR2013-002916-28-LV (EUCTR) | 12/12/2013 | 16/10/2013 | An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis | An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ATX-MS-1467 Product Code: MSC2358825A INN or Proposed INN: MSC2304479A INN or Proposed INN: MSC2304480A INN or Proposed INN: MSC2304481A INN or Proposed INN: MSC2304482A | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Russian Federation;Latvia | ||
| 327 | EUCTR2013-002283-25-FI (EUCTR) | 09/12/2013 | 25/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 328 | NCT02047734 (ClinicalTrials.gov) | December 3, 2013 | 26/1/2014 | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study) | A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients | Relapsing Multiple Sclerosis | Drug: Ozanimod 0.5 mg;Drug: Ozanimod 1 mg;Drug: Ozanimod placebo;Drug: Interferon ß-1a;Drug: IFN ß-1a placebo | Celgene | NULL | Completed | 18 Years | 55 Years | All | 1320 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Georgia;Greece;Hungary;Italy;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom |
| 329 | EUCTR2011-005677-23-BG (EUCTR) | 28/11/2013 | 15/11/2013 | Safety and efficacy of fingolimod in pediatric patients with multiple sclerosis | A two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Avonex INN or Proposed INN: interferon beta-1a Other descriptive name: INTERFERON BETA-1A Product Name: fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Service AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 330 | EUCTR2013-000529-30-GB (EUCTR) | 27/11/2013 | 17/10/2013 | prolonged-release oral fampridine in Neuromyelitis Optica (NMO), Pilot feasibility Study | A pilot study to assess efficacy of prolonged-Release oral fampridine on ambulation and visual function in Neuromyelitis Optica - Assessment of fampridine-PR in NMO | Neuromyelitis optica (NMO);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: fampyra 10mg prolonged release tablets | Walton Centre Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 331 | EUCTR2013-002283-25-HU (EUCTR) | 25/11/2013 | 08/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 332 | EUCTR2012-004165-41-GB (EUCTR) | 04/11/2013 | 19/09/2013 | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS | Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: natalizumab Trade Name: Fingolimod Product Name: Gilenya INN or Proposed INN: Fingolimod Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG-12 120 INN or Proposed INN: dimethyl fumarate | Northwestern University | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | United States;United Kingdom | ||
| 333 | NCT01982942 (ClinicalTrials.gov) | November 2013 | 29/10/2013 | Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis | A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects With Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Secondary Progressive | Drug: ibudilast;Drug: Placebo oral capsule | MediciNova | National Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS);National Multiple Sclerosis Society | Completed | 21 Years | 65 Years | All | 255 | Phase 2 | United States |
| 334 | NCT03133403 (ClinicalTrials.gov) | November 2013 | 21/4/2016 | Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT) | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Recruiting | 18 Years | 55 Years | All | 5 | Phase 2/Phase 3 | United Kingdom |
| 335 | EUCTR2013-002283-25-IT (EUCTR) | 29/10/2013 | 08/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 336 | EUCTR2012-004019-29-PL (EUCTR) | 07/10/2013 | 02/09/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | United States;Portugal;Finland;Spain;Turkey;Russian Federation;Colombia;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 337 | NCT01963611 (ClinicalTrials.gov) | October 2013 | 11/10/2013 | Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1) | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Plovamer acetate 0.5 milligram (mg);Drug: Copaxone 20 mg;Drug: Plovamer acetate 3 mg;Drug: Plovamer acetate 10 mg;Drug: Plovamer acetate 20 mg | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 255 | Phase 2 | United States;Bulgaria;Croatia;Czech Republic;Finland;Greece;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Germany |
| 338 | NCT01911377 (ClinicalTrials.gov) | October 2013 | 25/7/2013 | Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS | The Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple Sclerosis | Neuropathic Pain;Allodynia | Drug: Botulinum Toxin Type A;Drug: Normal Saline for Injection | University of Manitoba | Allergan | Terminated | 18 Years | 70 Years | Both | 12 | Phase 2 | Canada |
| 339 | EUCTR2011-006262-40-GB (EUCTR) | 24/09/2013 | 03/07/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 340 | EUCTR2012-004019-29-DE (EUCTR) | 19/09/2013 | 06/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: Secukinumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 341 | EUCTR2012-002639-27-BE (EUCTR) | 02/09/2013 | 06/02/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 342 | EUCTR2012-005262-35-GB (EUCTR) | 14/08/2013 | 11/06/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 343 | EUCTR2012-002714-40-ES (EUCTR) | 02/08/2013 | 09/04/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 344 | EUCTR2012-004019-29-PT (EUCTR) | 02/08/2013 | 03/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 345 | NCT01864148 (ClinicalTrials.gov) | August 2013 | 24/5/2013 | Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex | Multiple Sclerosis | Drug: BIIB033;Other: Placebo;Drug: Avonex | Biogen | NULL | Completed | 18 Years | 58 Years | All | 419 | Phase 2 | United States;Canada;Czech Republic;France;Hungary;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom |
| 346 | NCT01890655 (ClinicalTrials.gov) | August 2013 | 26/6/2013 | Extension Study of MT-1303 | A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study | Relapsing-remitting Multiple Sclerosis | Drug: MT-1303-Low;Drug: MT-1303-Middle;Drug: MT-1303-High | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 18 Years | 60 Years | Both | 367 | Phase 2 | Belgium;Bulgaria;Canada;Croatia;Czech Republic;Finland;Germany;Hungary;Italy;Lithuania;Poland;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom |
| 347 | EUCTR2012-003176-39-GB (EUCTR) | 31/07/2013 | 12/04/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 348 | EUCTR2012-004019-29-CZ (EUCTR) | 18/07/2013 | 13/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 349 | EUCTR2012-004807-10-DE (EUCTR) | 17/07/2013 | 26/10/2012 | Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis | Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis | MS patients who suffer from severe Optic Neuritis without satisfying improvement after treatment with steroids (3-5 days with 1 g daily at least 7 days prior to randomization) and with persisting visual acuity < 0.7, duration of symptoms should be = 4 weeks MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Urbason® solubile forte 1000 mg Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE | University Medical Center Hamburg Eppendorf | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Germany | ||
| 350 | EUCTR2012-002714-40-GR (EUCTR) | 10/07/2013 | 17/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 16.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 351 | EUCTR2012-004019-29-IT (EUCTR) | 10/07/2013 | 11/01/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebocontrolled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Product Name: Secukinumab Product Code: AIN | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2 | United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;Canada;Argentina;Poland;Germany;Japan;Sweden | ||
| 352 | EUCTR2011-006262-40-NL (EUCTR) | 03/07/2013 | 10/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: PRD806998 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 353 | NCT01896700 (ClinicalTrials.gov) | July 2013 | 8/7/2013 | Methylphenidate to Improve Balance and Walking in MS | Methylphenidate to Improve Balance and Walking in MS | Multiple Sclerosis | Drug: Methylphenidate;Drug: Placebo | Oregon Health and Science University | Portland VA Medical Center | Completed | 20 Years | 65 Years | All | 24 | Phase 2/Phase 3 | United States |
| 354 | NCT01647880 (ClinicalTrials.gov) | July 2013 | 23/7/2012 | MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study) | Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis | Multiple Sclerosis | Drug: Verum arm receiving Gilenya®;Drug: Active Comparator receiving Extavia® | Charite University, Berlin, Germany | NeuroCure Clinical Research Center, Charite, Berlin | Terminated | 18 Years | 55 Years | All | 15 | Phase 2/Phase 3 | Germany |
| 355 | NCT01710228 (ClinicalTrials.gov) | July 2013 | 4/9/2012 | Alternative Treatment Paradigm for Natalizumab Trial | Alternative Treatment Paradigm for Natalizumab Trial | Multiple Sclerosis (MS) | Drug: methylprednisolone | University of Texas Southwestern Medical Center | Teva Pharmaceutical Industries;The University of Texas Health Science Center, Houston;University of Alabama at Birmingham;Charite University, Berlin, Germany | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 2 | United States |
| 356 | EUCTR2011-006262-40-ES (EUCTR) | 28/06/2013 | 13/06/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: No disponible Other descriptive name: Anticuerpo monoclonal anti-LINGO-1 humano Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | France;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 357 | EUCTR2012-005262-35-ES (EUCTR) | 28/06/2013 | 13/06/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/mL, powder and solvent for solution for injection. Product Name: Betaferon INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 358 | EUCTR2012-004019-29-SE (EUCTR) | 19/06/2013 | 12/04/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 359 | EUCTR2012-004019-29-FI (EUCTR) | 19/06/2013 | 16/05/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 360 | EUCTR2011-006262-40-CZ (EUCTR) | 18/06/2013 | 05/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 361 | EUCTR2012-002714-40-HU (EUCTR) | 10/06/2013 | 02/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 362 | EUCTR2011-006262-40-HU (EUCTR) | 06/06/2013 | 25/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: Not available Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Czech Republic;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 363 | JPRN-JapicCTI-132178 | 01/6/2013 | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : AIN457 will be administered intravenously. Patients will be randomized to AIN457 Low/Middle/High dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching placebo will be administered intravenously. | Novartis Pharma K.K. | NULL | 18 | 55 | BOTH | 380 | Phase 2 | NULL | ||
| 364 | EUCTR2011-006262-40-IT (EUCTR) | 01/06/2013 | 08/04/2013 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Canada;Spain;Russian Federation;Netherlands;United Kingdom;Italy | ||
| 365 | NCT01717664 (ClinicalTrials.gov) | June 2013 | 24/10/2012 | Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS) | A Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of Fixed Dose Combination RHB-104 as Add-On Therapy to Interferon Beta-1a in Patients Treated for Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: RHB-104 | RedHill Biopharma Limited | NULL | Completed | 18 Years | N/A | Both | 18 | Phase 2 | Israel |
| 366 | NCT01874340 (ClinicalTrials.gov) | June 2013 | 28/5/2013 | Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: AIN457 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 55 Years | All | 28 | Phase 2 | Belgium;Czech Republic;France;Italy;Japan;Poland;Russian Federation;Spain;Sweden;Turkey;Canada;Finland;Germany;Romania;Switzerland;United States |
| 367 | EUCTR2012-004019-29-ES (EUCTR) | 24/05/2013 | 24/06/2013 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Other descriptive name: SECUKINUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Sweden | ||
| 368 | EUCTR2012-002639-27-IT (EUCTR) | 21/05/2013 | 11/04/2013 | A phase II, multicentre study to evaluate the long-term safety and efficacyof MT-1303 in subjects with relapsing-remitting multiple sclerosis whohave completed the MT-1303-E04 study | A phase II, multicentre study to evaluate the long-term safety and efficacyof MT-1303 in subjects with relapsing-remitting multiple sclerosis whohave completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 [0.1] Product Code: MT-1303 Product Name: MT-1303 [0.2] Product Code: MT-1303 Product Name: MT-1303 [0.4] Product Code: MT-1303 | MITSUBISHI TANABE PHARMA CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Bulgaria;Germany;Latvia;Sweden;Bosnia and Herzegovina | ||
| 369 | EUCTR2012-002714-40-BG (EUCTR) | 17/05/2013 | 08/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;South Africa;Moldova, Republic of;Bosnia and Herzegovina | ||
| 370 | EUCTR2012-002639-27-CZ (EUCTR) | 15/05/2013 | 28/02/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United Kingdom;Hungary;Czech Republic;Canada;Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden | ||
| 371 | EUCTR2012-002639-27-LT (EUCTR) | 10/05/2013 | 22/02/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 372 | EUCTR2012-002714-40-IT (EUCTR) | 09/05/2013 | 08/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Belgium;Croatia;Georgia;Bulgaria | ||
| 373 | NCT01845584 (ClinicalTrials.gov) | May 2013 | 26/4/2013 | Phase II Clinical Trial of NPB-01 in Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy. | NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Anti-aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder Not Provided Adequate Effect of Therapy to Steroids Plus Therapy. | Neuromyelitis Optica Spectrum Disorder | Drug: NPB-01 | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | N/A | All | 7 | Phase 2 | Japan |
| 374 | EUCTR2012-002639-27-BG (EUCTR) | 30/04/2013 | 13/03/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 375 | EUCTR2012-004019-29-BE (EUCTR) | 29/04/2013 | 23/10/2012 | Efficacy and safety of AIN457 to treat patients with relapsing multiple sclerosis | A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Secukinumab Product Code: AIN457 Other descriptive name: SECUKINUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Portugal;United States;Finland;Spain;Turkey;Russian Federation;Colombia;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan;Sweden | ||
| 376 | EUCTR2012-002714-40-BE (EUCTR) | 29/04/2013 | 14/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Sweden;Bosnia and Herzegovina | ||
| 377 | EUCTR2012-004436-36-DK (EUCTR) | 19/04/2013 | 22/04/2013 | Effect of rituximab in secondary progressive multiple sclerosis | A prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosis | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabThera (Rituximab) Product Name: MabThera INN or Proposed INN: RITUXIMAB | Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Denmark | ||
| 378 | EUCTR2012-005113-39-AT (EUCTR) | 08/04/2013 | 18/02/2013 | Amiloride Hydrochlorothiazide as Treatment of Acute Inflammation of the Optic Nerve. | A Randomized, Placebo-Controlled, Double-Blind, Phase IIa Study of Amiloride in the Treatment of Acute Autoimmune Optic Neuritis - Amiloride Hydrochlorothiazide in acute autoimmune optic neuritis | Optic neuritis is among the most common first symptoms of multiple sclerosis leading to significant atrophy of the optic nerve within a short period of time, thus reflecting neurodegneration.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Amilostad HCT Product Name: Amilostad HCT tablets INN or Proposed INN: AMILORIDE HYDROCHLORIDE, 2 H2O Other descriptive name: Amiloride Hydrochloride INN or Proposed INN: hydrochlorothiazide Other descriptive name: HYDROCHLOROTHIAZIDE | Universitätsklinik für Neurologie, Medizinische Universität Wien | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Austria | |||
| 379 | EUCTR2012-002639-27-PL (EUCTR) | 03/04/2013 | 04/03/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 380 | NCT01767701 (ClinicalTrials.gov) | April 2013 | 7/1/2013 | Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis | A Phase II Baseline Versus Treatment Study to Determine the Efficacy of Raltegravir (Isentress) in Preventing Progression of Relapsing Remitting Multiple Sclerosis as Determined by Gadolinium-enhanced MRI | Relapsing Remitting Multiple Sclerosis | Drug: Raltegravir | Queen Mary University of London | Merck Sharp & Dohme Corp. | Completed | 18 Years | 55 Years | All | 23 | Phase 2 | United Kingdom |
| 381 | EUCTR2010-021219-17-GR (EUCTR) | 19/03/2013 | 30/01/2013 | A clinical study to compare the efficacy and safety of masitinib 4.5 mg/kg/day vs. placebo in the treatment of patients with multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovakia;Greece;Poland;Spain;Turkey;Bulgaria;Germany | ||
| 382 | EUCTR2012-002639-27-GB (EUCTR) | 11/03/2013 | 20/11/2012 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Switzerland;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 383 | EUCTR2012-002470-31-LT (EUCTR) | 06/03/2013 | 05/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 384 | NCT01714089 (ClinicalTrials.gov) | March 2013 | 19/10/2012 | Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis | A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: RNS60 125 ml;Drug: RNS60 250 ml;Drug: Interferon beta 1a | Revalesio Corporation | NULL | Withdrawn | 18 Years | 50 Years | Both | 0 | Phase 2 | United States |
| 385 | EUCTR2012-002639-27-ES (EUCTR) | 27/02/2013 | 09/01/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 386 | EUCTR2012-000835-18-DE (EUCTR) | 26/02/2013 | 06/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 387 | EUCTR2012-002470-31-BE (EUCTR) | 25/02/2013 | 22/10/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 388 | EUCTR2012-002639-27-FI (EUCTR) | 19/02/2013 | 29/01/2013 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 389 | EUCTR2012-003627-38-BG (EUCTR) | 01/02/2013 | 21/11/2012 | Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK2395612 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 114 | Phase 2 | Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden | ||
| 390 | NCT01772199 (ClinicalTrials.gov) | February 2013 | 17/1/2013 | Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK239512;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 50 Years | Both | 131 | Phase 2 | Bulgaria;Canada;Czech Republic;Germany;Spain;Sweden;Ukraine;United Kingdom |
| 391 | NCT01802489 (ClinicalTrials.gov) | February 2013 | 27/2/2013 | Amiloride Clinical Trial In Optic Neuritis | A Double Blind Randomised Control Trial on Neuroprotection of Amiloride in Optic Neuritis | Optic Neuritis;Multiple Sclerosis | Drug: Amiloride;Drug: Placebo | University of Oxford | Multiple Sclerosis Society of Great Britain and Northern Ireland | Completed | 18 Years | 55 Years | All | 46 | Phase 2 | United Kingdom |
| 392 | EUCTR2012-002470-31-BG (EUCTR) | 30/01/2013 | 03/01/2013 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden | ||
| 393 | EUCTR2012-004183-21-GB (EUCTR) | 25/01/2013 | 14/12/2012 | Melatonin for Nocturia in patients with Multiple Sclerosis | A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension study - Melatonin for Nocturia in MS | Nocturia; Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Circadin Product Name: Circadin Product Code: N/A INN or Proposed INN: Circadin ( INN= Melatonin) | North Bristol NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 394 | EUCTR2012-002470-31-IT (EUCTR) | 21/01/2013 | 13/12/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebocontrolled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 Product Name: MT-1303 Product Code: MT-1303 Product Name: MT-1303 Product Code: MT-1303 | MITSUBISHI PHARMA CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Bosnia and Herzegovina | ||
| 395 | EUCTR2012-002470-31-ES (EUCTR) | 16/01/2013 | 05/02/2013 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 396 | EUCTR2012-004847-61-GB (EUCTR) | 16/01/2013 | 18/12/2012 | INSPIRE: Raltegravir (Isentress) Pilot Study in Relapsing MS | A phase II baseline versus treatment study to determine the efficacy of raltegravir (ISENTRESS) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI - INSPIRE (Isentress Pilot Study in Relapsing MS) | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: ISENTRESS Product Name: raltegravir INN or Proposed INN: lactose monohydrate | Queen Mary University of London | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United Kingdom | ||
| 397 | EUCTR2012-003627-38-GB (EUCTR) | 15/01/2013 | 21/11/2012 | Assessing the Potential Ability of GSK239512 to Remyelinate Brain Lesions in Relapsing Remitting Multiple Sclerosis | Proof of Mechanism Study to Assess the Potential of GSK239512 to Remyelinate Lesions in Subjects with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone Product Code: GSK239512 INN or Proposed INN: 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 114 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Canada;Spain;Ukraine;Bulgaria;Germany;United Kingdom;Sweden | ||
| 398 | EUCTR2012-002470-31-FI (EUCTR) | 14/01/2013 | 02/10/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 399 | EUCTR2012-004602-97-ES (EUCTR) | 11/01/2013 | 12/11/2012 | ?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial? | ?Vitamin D as add-on treatment for relapsing-remitting multiple sclerosis: an unicentric, randomized, double-blinded, placebo-controlled clinical trial? - VITADEM | RELAPSING-REMITING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA INN or Proposed INN: COLECALCIFEROL Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM) | Javier Olascoaga Urtaza | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain | ||
| 400 | EUCTR2012-002639-27-HU (EUCTR) | 10/01/2013 | 22/11/2012 | A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study. | A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 401 | NCT01753375 (ClinicalTrials.gov) | January 2013 | 17/12/2012 | Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis | Role of Vitamin D on the Relapse Rate of Multiple Sclerosis | Multiple Sclerosis | Dietary Supplement: Vitamin D3;Dietary Supplement: Placebo | AlJohara M AlQuaiz, M.D. | NULL | Not yet recruiting | 18 Years | 55 Years | Both | 200 | Phase 2 | Saudi Arabia |
| 402 | NCT01742052 (ClinicalTrials.gov) | January 2013 | 2/12/2012 | Dose-finding Study of MT-1303 | A Phase II, Multicentre, Randomised, Double-blind,Parallel Group, Placebo-controlled, Dose-finding Study to Evaluate the Safety and Efficacy of Three Different Oral Doses of MT-1303 Administered for a Period of 24 Weeks in Subjects With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: MT-1303-Low;Drug: MT-1303-Middle;Drug: MT-1303-High;Drug: Placebo | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 18 Years | 60 Years | Both | 415 | Phase 2 | Belgium;Bulgaria;Canada;Croatia;Czech Republic;Finland;Germany;Hungary;Italy;Lithuania;Poland;Russian Federation;Serbia;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 403 | NCT02249676 (ClinicalTrials.gov) | January 2013 | 15/9/2014 | Autologous Mesenchymal Stem Cells for the Treatment of Neuromyelitis Optica Spectrum Disorders | Autologous Mesenchymal Stem Cells for the Treatment of Progressive and Refractory Neuromyelitis Optica Spectrum Disorders: an Open-label Phase 2a Proof-of-concept Study | Devic's Syndrome;Devic's Neuromyelitis Optica;Devic Syndrome;Devic's Disease;Devic Disease | Biological: Autologous mesenchymal stem cells | Tianjin Medical University General Hospital | NULL | Completed | 18 Years | 80 Years | All | 15 | Phase 2 | China |
| 404 | EUCTR2012-003647-30-GB (EUCTR) | 20/12/2012 | 23/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) consisting of two parts: First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 405 | EUCTR2012-002470-31-PL (EUCTR) | 17/12/2012 | 21/12/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Turkey;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 406 | EUCTR2012-003056-36-EE (EUCTR) | 13/12/2012 | 09/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 407 | EUCTR2012-000721-53-SE (EUCTR) | 07/12/2012 | 16/10/2012 | An extension trial of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis | ITT-PMS ExtensionAn extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis - ITT-PMS Ext | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB | Dept of Neurology, Umeå University Hospital, Umeå, Sweden | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Sweden | ||
| 408 | EUCTR2012-002470-31-CZ (EUCTR) | 04/12/2012 | 11/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden | ||
| 409 | NCT01879202 (ClinicalTrials.gov) | December 2012 | 7/11/2012 | Methylphenidate as Treatment Option of Fatigue in Multiple Sclerosis | Methylphenidate Modified-release as Treatment of MS-associated Fatigue. A Single-center Randomized Double-blind Placebo-controlled Study. | Multiple Sclerosis;Fatigue | Drug: Methylphenidate modified release;Drug: Maltodextrin | Medical University of Vienna | NULL | Recruiting | 18 Years | N/A | Both | 96 | Phase 2 | Austria |
| 410 | EUCTR2012-002470-31-HU (EUCTR) | 08/11/2012 | 25/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 411 | EUCTR2012-003056-36-CZ (EUCTR) | 08/11/2012 | 12/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 412 | NCT01679041 (ClinicalTrials.gov) | November 2012 | 29/8/2012 | High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior Treatment | A Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of Therapy | Multiple Sclerosis | Drug: Alemtuzumab;Drug: Fludarabine;Drug: Cyclophosphamide | Seah Lim M.D. | NULL | Terminated | 18 Years | 60 Years | Both | 1 | Phase 2 | United States |
| 413 | NCT01744444 (ClinicalTrials.gov) | November 2012 | 30/11/2012 | Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis | Pendular Nystagmus Patients With Multiple Sclerosis | Drug: Memantine;Drug: Gabapentin | Hospices Civils de Lyon | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 2 | France | |
| 414 | EUCTR2012-003056-36-HU (EUCTR) | 31/10/2012 | 03/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 415 | EUCTR2012-002470-31-GB (EUCTR) | 29/10/2012 | 03/09/2012 | A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths | A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Switzerland;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina | ||
| 416 | EUCTR2012-002357-35-GB (EUCTR) | 23/10/2012 | 26/07/2012 | Bone marrow stem cells to treat multiple sclerosis | Stem cells in Rapidly Evolving Active Multiple Sclerosis (STREAMS) - Stem cells in Rapidly Evolving Active Multiple Sclerosis (STREAMS) | Multiple Sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Autologous Mesenchymal Cell Product | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 13 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 417 | EUCTR2012-003418-15-AT (EUCTR) | 23/10/2012 | 09/11/2012 | Methylphenidate modified release as treatment of MS-associated fatigue. | Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial. | Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ritalin LA 20mg capsules Product Name: Methylphenidate modified release 20 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 30mg capsules Product Name: Methylphenidate modified release 30 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 40mg capsules Product Name: Methylphenidate modified release 40 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE | Medizinische Universität Wien | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Austria | ||
| 418 | EUCTR2012-002694-66-FI (EUCTR) | 12/10/2012 | 08/10/2012 | Effect of fingolimod on cardiac autonomic regulation in MS-patients | Effect of fingolimod on cardiac autonomic regulation in MS-patients | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | Sakari Simula | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland | ||
| 419 | EUCTR2012-000635-68-IE (EUCTR) | 19/09/2012 | 09/02/2012 | An initial, short-duration study of vitamin D versus an inactive therapy on the ability of the human immune system to counteract the effects of Multiple Sclerosis on the brain and the effects of vitamin D on the immune system in healthy individuals. | Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome or early multiple sclerosis and healthy control participants. An exploratory randomised double blind placebo controlled study - N/A | Multiple Sclerosis MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Product Name: N/A Product Code: N/A | University College Dublin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Ireland | |||
| 420 | NCT01628393 (ClinicalTrials.gov) | September 18, 2012 | 22/6/2012 | Efficacy and Safety Study of RPC1063 in Relapsing Multiple Sclerosis Patients (Radiance Study) | A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients | Relapsing Multiple Sclerosis | Drug: RPC1063;Drug: placebo | Celgene | NULL | Completed | 18 Years | 55 Years | All | 258 | Phase 2/Phase 3 | United States;Belgium;Bulgaria;Georgia;Greece;Hungary;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine |
| 421 | EUCTR2010-023210-31-LT (EUCTR) | 12/09/2012 | 29/05/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 422 | EUCTR2010-023210-31-CZ (EUCTR) | 06/09/2012 | 13/06/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 423 | NCT01667497 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? | Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? A Cross Over Study | Cognitive Fatigue | Drug: Fampridine SR;Drug: Placebo | London Health Sciences Centre | NULL | Completed | 18 Years | 64 Years | Both | 60 | Phase 2/Phase 3 | Canada |
| 424 | NCT01413243 (ClinicalTrials.gov) | September 2012 | 8/8/2011 | Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome | Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome - A Monocentric, Prospective, Randomized, Double-blind and Placebo-controlled Phase 2 Trial | Multiple Sclerosis | Drug: Trichuris suis ova | Charite University, Berlin, Germany | NULL | Terminated | 18 Years | 65 Years | Both | 50 | Phase 2 | Germany |
| 425 | NCT02442570 (ClinicalTrials.gov) | September 2012 | 1/5/2015 | A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple Sclerosis | A Phase IIa, Randomized, Double-blind, Placebo-controlled, Exploratory, Dose-ranging Study to Evaluate the Safety, Effectiveness and Pharmacokinetics of Three Courses of DC-TAB Treatment in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: recombinant human alpha B-crystallin;Other: Placebo comparator | Delta Crystallon BV | NULL | Completed | 18 Years | 55 Years | Both | 32 | Phase 2 | Bulgaria |
| 426 | NCT01667484 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | Adderall XR and Processing Speed in Multiple Sclerosis (MS) | Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients? | Impaired Processing Speed;Cognitive Impairment;Multiple Sclerosis | Drug: Adderall XR 5mg;Drug: Adderall XR 10 mg;Drug: Placebo | London Health Sciences Centre | NULL | Completed | 18 Years | 59 Years | Both | 70 | Phase 2/Phase 3 | Canada |
| 427 | EUCTR2012-000368-90-BE (EUCTR) | 08/08/2012 | 11/06/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Canada;Belgium;Netherlands;Italy;United Kingdom;Sweden | ||
| 428 | NCT01684761 (ClinicalTrials.gov) | August 2012 | 11/9/2012 | Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis | A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis | Autoimmune Diseases of the Nervous System;Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Disease Progression;Brain Atrophy | Biological: Tcelna;Biological: Placebo | Opexa Therapeutics, Inc. | NULL | Completed | 18 Years | 60 Years | All | 183 | Phase 2 | United States;Canada |
| 429 | NCT01597297 (ClinicalTrials.gov) | August 2012 | 10/5/2012 | Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: BIIB041 (PR Fampridine);Other: Placebo | Biogen | NULL | Completed | 18 Years | 70 Years | All | 132 | Phase 2 | Belgium;Canada;Italy;Netherlands;Sweden;United Kingdom |
| 430 | NCT01639300 (ClinicalTrials.gov) | July 2012 | 10/7/2012 | Safety Study of GNbAC1 in Multiple Sclerosis Patients | Randomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1 | Multiple Sclerosis | Biological: GNbAC1;Biological: GNbAC1 placebo | GeNeuro Innovation SAS | NULL | Completed | 18 Years | 65 Years | All | 10 | Phase 2 | Switzerland |
| 431 | EUCTR2012-000518-13-DK (EUCTR) | 21/06/2012 | 21/06/2012 | Own mesenchymal stem cells for multiple sclerosis patients | Immunomodulating and neuroprotective properties of autologous multipotent mesenchymal stem cells in patients with multiple sclerosis - A randomised placebo-controlled double-blinded phase II study - COMSCIMS | Multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mesenchymal stem/stromal cells Product Name: Mesenchymal stem cells (MSCs) | Prof. Per Soelberg Sørensen | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 432 | EUCTR2011-004475-36-BG (EUCTR) | 19/05/2012 | 10/04/2012 | A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis | A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DC-TAB Product Code: DC-TAB Other descriptive name: recombinant human alpha B-crystallin | Delta Crystallon B.V. | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Bulgaria | |||
| 433 | NCT01718678 (ClinicalTrials.gov) | May 2012 | 28/10/2012 | Effect of Melatonin on Multiple Sclerosis Related Fatigue | Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis | Fatigue | Drug: Melatonin;Drug: Placebo | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 55 Years | Both | 44 | Phase 2 | Iran, Islamic Republic of |
| 434 | NCT01514370 (ClinicalTrials.gov) | April 30, 2012 | 17/1/2012 | Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a | ProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW) | Multiple Sclerosis | Drug: IFN beta 1a 44 mcg TIW;Drug: Curcumin;Drug: Placebo | Merck KGaA, Darmstadt, Germany | Merck Serono S.P.A., Italy | Completed | 18 Years | 60 Years | All | 80 | Phase 2 | Italy |
| 435 | EUCTR2011-002178-22-GB (EUCTR) | 27/04/2012 | 29/03/2012 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 436 | EUCTR2010-023210-31-IT (EUCTR) | 27/04/2012 | 12/03/2012 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: DYSPORT*SC IM 2FL 500U INN or Proposed INN: BOTULINUM TOXIN TYPE A | IPSEN INNOVATION | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 437 | EUCTR2011-005606-30-GB (EUCTR) | 25/04/2012 | 02/04/2012 | Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H). | Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THY | This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab. MedDRA version: 14.1;Level: PT;Classification code 10058948;Term: Nephritis autoimmune;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10049046;Term: Autoimmune thyroiditis;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Level: LLT;Classification code 10068004;Term: Autoimmune hyperthyroidism;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kepivance Product Name: Kepivance INN or Proposed INN: Palifermin Trade Name: MabCampath Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Other descriptive name: anti-CD52 monoclonal antibody | Cambridge University Hospitals NHS Foundation Trust and University of Cambridge | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 438 | EUCTR2010-020337-99-NL (EUCTR) | 13/04/2012 | 19/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg /10ml Product Code: RO4964913 F07 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Netherlands;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 439 | NCT01627938 (ClinicalTrials.gov) | April 2012 | 30/5/2012 | Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in Combination | A Phase II Proof of Concept Study Evaluating the Reduction of Mitoxantrone-induced Cardiotoxicity and Neurological Outcome in the Combined Use of Mitoxantrone and Dexrazoxane (Cardioxane®) in Multiple Sclerosis (MSCardioPro) | Multiple Sclerosis | Drug: Dexrazoxane (DRZ) plus Mitoxantrone (MX);Drug: Placebo plus Mitoxantrone (MX) | PD Dr. Andrew Chan | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 50 | Phase 2 | Germany |
| 440 | EUCTR2010-020515-37-NO (EUCTR) | 22/03/2012 | 15/02/2011 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 441 | EUCTR2011-002178-22-PL (EUCTR) | 20/03/2012 | 25/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 15.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 442 | NCT01404117 (ClinicalTrials.gov) | March 2012 | 26/7/2011 | A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability | Relapsing Multiple Sclerosis | Drug: Laquinimod 0.6;Drug: Laquinimod 1.2;Other: Glatiramer Acetate or interferon-beta+ Placebo | Teva Pharmaceutical Industries | NULL | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 2 | NULL | |
| 443 | NCT01576354 (ClinicalTrials.gov) | March 2012 | 22/3/2012 | Characterization of the Effects of Prolonged-release Fampridine on Ambulatory Function in Patients With Multiple Sclerosis | A Phase IIb, Double-blind, Randomized, Mono-center, Placebo-controlled Study With Crossover Design Characterizing the Effects of Prolonged-release Fampridine Treatment on Ambulatory Function in Patients With Multiple Sclerosis Using Detailed Gait Analysis Based on Kinematic and Kinetic Parameters | Multiple Sclerosis | Drug: Prolonged-release Fampridine;Drug: Placebo | University of Zurich | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 70 | Phase 2 | Switzerland |
| 444 | EUCTR2010-023210-31-DE (EUCTR) | 24/02/2012 | 09/11/2011 | The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 15.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 445 | EUCTR2010-023210-31-AT (EUCTR) | 23/02/2012 | 18/01/2012 | The aim of the study is to assess the efficacy and safety of intra -detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis. | A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS | NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 15.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dysport Product Name: Dysport INN or Proposed INN: CLOSTRIDIUM BOTULINUM TOXIN TYPE A Other descriptive name: BOTULINUM TOXIN TYPE A | Ipsen Innovation | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Czech Republic;Lithuania;Austria;Germany;Italy | ||
| 446 | EUCTR2011-002178-22-CZ (EUCTR) | 08/02/2012 | 02/11/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A Product Name: Dextromethorphan/Quinidine Product Code: AVP-923 INN or Proposed INN: DEXTROMETHORPHAN HYDROBROMIDE Other descriptive name: N/A INN or Proposed INN: Quinidine Sulfate Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Spain;Poland;Bulgaria;Germany;United Kingdom | ||
| 447 | EUCTR2010-021219-17-SK (EUCTR) | 01/02/2012 | 06/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Tunisia;Germany;Bosnia and Herzegovina | ||
| 448 | NCT01569451 (ClinicalTrials.gov) | February 2012 | 30/3/2012 | Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate | A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Rituximab;Drug: Glatiramer Acetate;Other: Placebo | University of Colorado, Denver | Rocky Mountain MS Research Group, LLC | Completed | 18 Years | 55 Years | All | 53 | Phase 2 | United States |
| 449 | NCT01433250 (ClinicalTrials.gov) | February 2012 | 26/8/2011 | A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis | An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: AIN457 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 39 | Phase 2 | Czech Republic;Russian Federation;Ukraine |
| 450 | NCT01516554 (ClinicalTrials.gov) | February 2012 | 19/1/2012 | Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients | A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients | Multiple Sclerosis;Fatigue | Drug: Testosterone undecanoate;Drug: placebo | Health Sciences Centre, Winnipeg, Manitoba | University of Manitoba;Consortium of Multiple Sclerosis Centers;Manitoba Medical Service Foundation | Terminated | 18 Years | 65 Years | Male | 3 | Phase 2 | Canada |
| 451 | EUCTR2010-020328-23-PT (EUCTR) | 06/01/2012 | 17/11/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA - Geneva, an affiliate of Merck KGaA | ,NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 452 | EUCTR2011-002178-22-ES (EUCTR) | 26/12/2011 | 31/10/2011 | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis | Central Neuropathic Pain in Multiple Sclerosis MedDRA version: 14.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HIDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HiDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A Product Name: Dextrometorfano/Quinidina Product Code: AVP-923 INN or Proposed INN: DEXTROMETORFANO HIDROBROMURO Other descriptive name: N/A INN or Proposed INN: Quinidina sulfato Other descriptive name: N/A | Avanir Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;Czech Republic;Argentina;Poland;Spain;Bulgaria;United Kingdom | ||
| 453 | NCT02006160 (ClinicalTrials.gov) | December 2011 | 6/6/2012 | Effects of Dalfampridine on Cognition in Multiple Sclerosis | Effects of Dalfampridine on Cognition in Multiple Sclerosis | Multiple Sclerosis | Drug: dalfampridine;Drug: placebo | State University of New York at Buffalo | NULL | Completed | 18 Years | 60 Years | All | 61 | Phase 2/Phase 3 | United States |
| 454 | NCT01440062 (ClinicalTrials.gov) | December 2011 | 19/9/2011 | Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS) | Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis | Multiple Sclerosis | Drug: Verum arm receiving Vitamin D oil;Drug: low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day | Charite University, Berlin, Germany | NeuroCure Clinical Research Center, Charite, Berlin | Terminated | 18 Years | 65 Years | All | 55 | Phase 2 | Germany |
| 455 | NCT01470521 (ClinicalTrials.gov) | December 2011 | 9/11/2011 | Worms for Immune Regulation of Multiple Sclerosis | Worms for Immune Regulation of Multiple Sclerosis (WIRMS) | Multiple Sclerosis, Relapsing-Remitting | Biological: Hookworm larvae;Biological: Placebo | University of Nottingham | National Multiple Sclerosis Society | Completed | 18 Years | 65 Years | Both | 72 | Phase 2 | United Kingdom |
| 456 | EUCTR2011-002333-19-DK (EUCTR) | 25/11/2011 | 18/10/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 2 | United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy | ||
| 457 | EUCTR2010-020328-23-AT (EUCTR) | 23/11/2011 | 28/10/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA - Geneva, an affiliate of Merck KGaA | ,NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Hungary;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 458 | EUCTR2009-015319-41-DE (EUCTR) | 03/11/2011 | 04/02/2011 | Trichuris suis Oozyten (TSO®) in remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS) | Trichuris suis Oozyten (TSO®) in remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS) - TRIOMS | remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS);Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Product Name: TSO Product Code: TSO INN or Proposed INN: Trichuris suis ova (eggs), embryonated, viable | Charite Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 459 | NCT01457924 (ClinicalTrials.gov) | November 1, 2011 | 20/10/2011 | Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Ofatumumab 3mg;Drug: Ofatumumab 30mg;Drug: Ofatumumab 60mg;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 232 | Phase 2 | United States;Bulgaria;Canada;Czechia;Denmark;Germany;Italy;Netherlands;Norway;Russian Federation;Spain;Czech Republic |
| 460 | NCT01451593 (ClinicalTrials.gov) | November 2011 | 11/10/2011 | Neuroprotection With Phenytoin in Optic Neuritis | A Phase II Double Blind, Randomized, Placebo Controlled Trial of Neuroprotection With Phenytoin in Acute Optic Neuritis | Optic Neuritis;Multiple Sclerosis | Drug: Phenytoin;Drug: Placebo | University College, London | National Multiple Sclerosis Society;Multiple Sclerosis Society of Great Britain and Northern Ireland | Completed | 18 Years | 60 Years | Both | 92 | Phase 2 | United Kingdom |
| 461 | EUCTR2010-021219-17-DE (EUCTR) | 31/10/2011 | 05/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate INN or Proposed INN: masitinb mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate INN or Proposed INN: masitinb mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Germany;Tunisia;Bosnia and Herzegovina | ||
| 462 | EUCTR2010-024000-10-IT (EUCTR) | 26/10/2011 | 27/12/2011 | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI*IV 1FL 300MG 15ML Trade Name: TYSABRI*IV 1FL 300MG 15ML | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Spain;Belgium;Germany;Italy | ||
| 463 | EUCTR2011-002333-19-ES (EUCTR) | 21/10/2011 | 28/09/2011 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months? administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra® Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline SA | NULL | Not Recruiting | Female: yes Male: yes | 196 | Phase 2 | United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy | ||
| 464 | NCT01466114 (ClinicalTrials.gov) | October 2011 | 31/10/2011 | Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition | A Double-Blind, Placebo Controlled Trial of Estriol Treatment in Women With Multiple Sclerosis: Effect on Cognition. | Relapsing-remitting Multiple Sclerosis;Secondary-progressive Multiple Sclerosis;Primary-progressive Multiple Sclerosis | Drug: estriol;Other: Placebo;Drug: Norethindrone;Other: Progestin Placebo | University of California, Los Angeles | NULL | Recruiting | 18 Years | 55 Years | Female | 64 | Phase 2 | United States |
| 465 | EUCTR2009-017978-21-DK (EUCTR) | 21/09/2011 | 12/09/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 466 | EUCTR2011-002785-20-DE (EUCTR) | 19/09/2011 | 11/08/2011 | Efficacy of Vitamin D Supplementation in relapsing-remitting Multiple Sclerosis | Efficacy of Vitamin D Supplementation in relapsing-remitting Multiple Sclerosis - EVIDIMS | Multiple Sclerosis and Clinical isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol® Öl 20.000 I.E./ml Product Name: Vigantol® Öl 20.000 I.E./ml Product Code: Vigantol® Öl 20.000 I.E./ml INN or Proposed INN: COLECALCIFEROL Trade Name: Dekristol®-Tablette 1 (400 IE) Product Name: Dekristol® 400-Tabletten Product Code: Dekristol® 400-Tabletten INN or Proposed INN: COLECALCIFEROL Other descriptive name: 25OH-Vitamin D | Charité - Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
| 467 | EUCTR2010-021219-17-ES (EUCTR) | 12/09/2011 | 01/07/2011 | Evaluación de masitinib en esclerosis múltiple | Estudio prospectivo Fase III, multicéntrico, randomizado, doble ciego, de dos grupos paralelos, controlado con placebo y de 96 semanas de duración, para comparar la eficacia y seguridad de masitinib a la dosis de 6 mg/kg/día con placebo en el tratamiento de pacientes con esclerosis múltiple primaria progresiva o esclerosis múltiple secundaria progresiva sin recidiva | Pacientes con esclerosis múltiple primaria progresiva o secundaria progresiva sin recidiva MedDRA version: 14.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Slovakia;Greece;Poland;Spain;Romania;Bulgaria;Germany | ||
| 468 | NCT01403376 (ClinicalTrials.gov) | September 2011 | 14/7/2011 | Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide | Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference | Multiple Sclerosis | Drug: teriflunomide;Drug: Interferon-ß-1;Biological: Influenza vaccine | Sanofi | NULL | Completed | 18 Years | 59 Years | All | 128 | Phase 2 | Austria;Canada;Germany;Russian Federation;Ukraine |
| 469 | NCT01450124 (ClinicalTrials.gov) | September 2011 | 18/9/2011 | Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA) | Safety, Tolerability And Mechanism Of Action Of Boswellic Acids In Multiple Sclerosis and Clinically Isolated Syndrome: A MRI-Controlled, Multicenter, Baseline-To-Treatment, 32-Weeks, Open-Label, Phase IIa Trial | Relapsing Remitting Multiple Sclerosis | Drug: Boswellic acids (BOSWELAN) | Universitätsklinikum Hamburg-Eppendorf | NULL | Completed | 18 Years | 65 Years | All | 29 | Phase 2 | Germany |
| 470 | NCT01444300 (ClinicalTrials.gov) | September 2011 | 20/9/2011 | Dalfampridine for Imbalance in Multiple Sclerosis | Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study | Multiple Sclerosis;Fatigue | Drug: Dalfampridine;Drug: Placebo | Oregon Health and Science University | Acorda Therapeutics | Completed | 20 Years | 59 Years | All | 24 | Phase 2 | United States |
| 471 | NCT01324232 (ClinicalTrials.gov) | September 2011 | 23/3/2011 | Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis | Central Neuropathic Pain;Multiple Sclerosis | Drug: AVP-923;Drug: Placebo | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 200 | Phase 2 | United States;Argentina;Czechia;Poland;Spain;Czech Republic;Germany;United Kingdom |
| 472 | EUCTR2010-023048-34-DE (EUCTR) | 31/08/2011 | 10/05/2011 | A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of low doses of oral Diazoxide for the treatment of Multiple Sclerosis. | A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of low doses of oral Diazoxide for the treatment of Multiple Sclerosis. - NeuroAdvan | Multiple Sclerosis Treatment. MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Diazoxide Product Code: Diazoxide INN or Proposed INN: Diazoxide Product Name: Diazoxide Product Code: Diazoxide INN or Proposed INN: Diazoxide | NEUROTEC PHARMA, S.L | NULL | Not Recruiting | Female: yes Male: yes | 99 | Phase 2 | Spain;Germany | ||
| 473 | EUCTR2010-024000-10-ES (EUCTR) | 08/08/2011 | 26/05/2011 | A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Belgium;Spain;Germany;Italy | ||
| 474 | NCT01405820 (ClinicalTrials.gov) | August 2011 | 14/7/2011 | Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS) | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: natalizumab IV;Drug: natalizumab SC;Drug: IV Placebo;Drug: SC Placebo | Biogen | NULL | Completed | 18 Years | 55 Years | All | 290 | Phase 2 | Belgium;France;Germany;Italy;Spain |
| 475 | EUCTR2010-021978-11-GB (EUCTR) | 26/07/2011 | 04/04/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 476 | EUCTR2010-024000-10-DE (EUCTR) | 19/07/2011 | 21/04/2011 | A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Spain;Belgium;Germany;Italy | ||
| 477 | EUCTR2010-020328-23-LV (EUCTR) | 19/07/2011 | 16/05/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Latvia;Norway;Germany;Netherlands | ||
| 478 | EUCTR2009-017978-21-ES (EUCTR) | 13/07/2011 | 17/11/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina. MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 479 | EUCTR2009-017978-21-BE (EUCTR) | 12/07/2011 | 29/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Arab Emirates;Portugal;Serbia;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 480 | EUCTR2008-005008-24-GB (EUCTR) | 07/07/2011 | 19/05/2011 | Worms for immune regulation of multiple sclerosis - MS and hookworm | Worms for immune regulation of multiple sclerosis - MS and hookworm | Relapsing Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Necator americanus Other descriptive name: Live Necator americanus larvae | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 481 | NCT01451723 (ClinicalTrials.gov) | July 2011 | 11/10/2011 | Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II | Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS | Multiple Sclerosis | Drug: Polyphenon E;Other: Placebo | Louisiana State University Health Sciences Center in New Orleans | National Center for Complementary and Integrative Health (NCCIH) | Terminated | 18 Years | 60 Years | All | 11 | Phase 2 | United States |
| 482 | NCT01103583 (ClinicalTrials.gov) | July 2011 | 13/4/2010 | Hydroxyurea in Primary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Hydroxyurea;Other: placebo | S. Andrea Hospital | NULL | Terminated | 18 Years | 60 Years | Both | 33 | Phase 2/Phase 3 | Italy | |
| 483 | EUCTR2010-024000-10-BE (EUCTR) | 28/06/2011 | 08/04/2011 | A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Spain;Belgium;Germany;Italy | ||
| 484 | EUCTR2009-015318-23-DE (EUCTR) | 09/06/2011 | 08/06/2010 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 485 | EUCTR2009-017978-21-SE (EUCTR) | 08/06/2011 | 03/05/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 486 | EUCTR2009-017978-21-FI (EUCTR) | 07/06/2011 | 28/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 487 | NCT01428726 (ClinicalTrials.gov) | June 2011 | 31/8/2011 | A Phase IIa Study of NT-KO-003 for Multiple Sclerosis | A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of Low Doses of Oral NT-KO-003 for the Treatment of Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: NT-KO-003 | Neurotec Pharma | Advancell - Advanced In Vitro Cell Technologies, S.A. | Completed | 18 Years | 55 Years | Both | 99 | Phase 2 | Germany;Spain |
| 488 | EUCTR2010-020328-23-LT (EUCTR) | 09/05/2011 | 02/03/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oil Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 489 | EUCTR2009-017978-21-LV (EUCTR) | 06/05/2011 | 18/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 490 | EUCTR2009-017978-21-AT (EUCTR) | 05/05/2011 | 31/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 491 | NCT01357980 (ClinicalTrials.gov) | May 2011 | 17/5/2011 | Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis | A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis. | Detrusor Muscle Hyperactivity | Biological: Botulinum toxin type A;Drug: Placebo | Ipsen | NULL | Completed | 18 Years | 70 Years | All | 47 | Phase 2 | Czechia;France;Germany;Italy;Poland;Austria;Czech Republic |
| 492 | NCT01337986 (ClinicalTrials.gov) | May 2011 | 13/4/2011 | Ampyra for Optic Neuritis in Multiple Sclerosis | Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis | Multiple Sclerosis;Optic Neuritis | Drug: Dalfampridine/Placebo;Drug: Placebo/Dalfampridine | Washington University School of Medicine | Acorda Therapeutics | Completed | 18 Years | 55 Years | All | 53 | Phase 2/Phase 3 | United States |
| 493 | EUCTR2010-020328-23-EE (EUCTR) | 26/04/2011 | 21/03/2011 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 494 | EUCTR2009-017978-21-EE (EUCTR) | 21/04/2011 | 13/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 495 | EUCTR2010-020328-23-BE (EUCTR) | 01/04/2011 | 18/11/2010 | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono SA-Geneva an affiliate of Merck KgaA, Darmstadt | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 496 | NCT01305837 (ClinicalTrials.gov) | April 2011 | 28/2/2011 | Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis | Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: methylprednisolone | Rigshospitalet, Denmark | NULL | Completed | 18 Years | 65 Years | Both | 30 | Phase 2 | Denmark |
| 497 | EUCTR2010-020328-23-IT (EUCTR) | 10/03/2011 | 07/02/2011 | A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR | A THREE-ARM, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER, PHASE II STUDY TO EVALUATE THE EFFICACY OF VIGANTOL OIL AS ADD-ON THERAPY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH REBIF (SOLAR) - SOLAR | RELAPSING REMITTING MULTIPLE SCLEROSIS MedDRA version: 9.1;Level: PT;Classification code 10063399 | Trade Name: VIGANTOL OIL INN or Proposed INN: Colecalciferol | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 498 | EUCTR2010-023021-38-SE (EUCTR) | 23/02/2011 | 26/11/2010 | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB | Västerbottens läns landsting | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 499 | EUCTR2009-017978-21-BG (EUCTR) | 08/02/2011 | 11/09/2015 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 500 | NCT01285401 (ClinicalTrials.gov) | February 2011 | 26/1/2011 | Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment | A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif® | Relapsing-Remitting Multiple Sclerosis | Drug: VigantOL oil plus interferon beta-1a (Rebif);Drug: Placebo plus interferon beta-1a (Rebif);Biological: Interferon beta-1a (Rebif®) alone | Merck KGaA | NULL | Completed | 18 Years | 55 Years | All | 260 | Phase 2 | Austria;Denmark;Estonia;Finland;Germany;Italy;Latvia;Lithuania;Netherlands;Norway;Portugal;Switzerland;Belgium;Hungary |
| 501 | EUCTR2010-020328-23-DE (EUCTR) | 31/01/2011 | 27/10/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: CHOLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Italy;Switzerland;Belgium;Denmark;Germany;Latvia;Netherlands;Norway | ||
| 502 | EUCTR2010-020328-23-NL (EUCTR) | 06/01/2011 | 16/09/2010 | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono The Netherlands - a division of Merck B.V. | NULL | Not Recruiting | Female: yes Male: yes | 358 | Phase 2 | Portugal;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Netherlands;Italy | ||
| 503 | EUCTR2009-017978-21-DE (EUCTR) | 20/12/2010 | 22/11/2010 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 504 | EUCTR2009-017939-18-GB (EUCTR) | 15/12/2010 | 27/08/2010 | A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS | A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS | Chronic urinary tract infection. MedDRA version: 16.1;Level: LLT;Classification code 10059617;Term: Overactive bladder;System Organ Class: 100000004857 | Trade Name: Nitrofurantoin Product Name: Nitrofurantoin Product Code: PL 12762/0049 INN or Proposed INN: Nitrofurantoin Other descriptive name: Nitrofurantoin | University College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 505 | EUCTR2010-020328-23-DK (EUCTR) | 09/12/2010 | 08/11/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 506 | EUCTR2009-011470-15-NL (EUCTR) | 03/12/2010 | 03/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 507 | NCT01712373 (ClinicalTrials.gov) | December 2010 | 19/10/2012 | Ginseng in Treatment of Fatigue in Multiple Sclerosis | Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis | Fatigue | Drug: Ginseng;Drug: Placebo | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 50 Years | Both | 60 | Phase 2 | Iran, Islamic Republic of |
| 508 | NCT01228266 (ClinicalTrials.gov) | December 2010 | 25/10/2010 | Mesenchymal Stem Cell Transplantation in MS | Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study | Multiple Sclerosis | Biological: autologous mesenchymal stem cells | Albert Saiz | Instituto de Salud Carlos III | Terminated | 18 Years | 50 Years | Both | 9 | Phase 2 | Spain |
| 509 | EUCTR2010-020515-37-FR (EUCTR) | 19/11/2010 | 06/09/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 510 | NCT00939549 (ClinicalTrials.gov) | November 2010 | 14/7/2009 | High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis | Phase II Study of High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Cyclophosphamide/Glatiramer acetate | Johns Hopkins University | NULL | Withdrawn | 18 Years | 70 Years | All | 0 | Phase 2 | United States |
| 511 | NCT01440101 (ClinicalTrials.gov) | November 2010 | 14/4/2011 | Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B) | Multiple Sclerosis | Drug: Natalizumab (BG00002);Drug: Placebo | Biogen | NULL | Completed | 18 Years | 65 Years | All | 106 | Phase 2/Phase 3 | Japan;China |
| 512 | EUCTR2010-020328-23-FI (EUCTR) | 21/10/2010 | 27/08/2010 | Supplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. | A three-arm, randomized, double-blind, placebo controlled, multicenter,phase II study to evaluate the efficacy of Vigantol® oil as add-ontherapy in subjects with Relapsing-Remitting Multiple Sclerosis receivingtreatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patientswith Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol Oel Product Name: Vigantol Oil Product Code: 200106 or EMD 28162 INN or Proposed INN: COLECALCIFEROL Other descriptive name: Cholecalciferol, Vitamin D3 | Merck Serono | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 2 | Portugal;Estonia;Finland;Lithuania;Austria;Switzerland;Italy;Belgium;Denmark;Norway;Germany;Latvia;Netherlands | ||
| 513 | EUCTR2010-020515-37-PT (EUCTR) | 11/10/2010 | 23/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 514 | EUCTR2010-019029-32-BE (EUCTR) | 08/10/2010 | 03/08/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 2 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 515 | NCT01226745 (ClinicalTrials.gov) | October 2010 | 19/10/2010 | Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) | A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ONO-4641 | EMD Serono | Merck KGaA;Ono Pharmaceutical Co. Ltd | Terminated | 18 Years | 55 Years | All | 340 | Phase 2 | United States;Belgium;Canada;Czech Republic;Germany;Greece;Japan;Poland;Russian Federation;Spain;Ukraine |
| 516 | NCT01279876 (ClinicalTrials.gov) | October 2010 | 18/1/2011 | Melatonin in Relapsing-Remitting Multiple Sclerosis Patients | Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients | Multiple Sclerosis, Relapsing-Remitting | Drug: Melatonin | Tehran University of Medical Sciences | NULL | Completed | 20 Years | 45 Years | Both | 25 | Phase 2 | Iran, Islamic Republic of |
| 517 | NCT01188811 (ClinicalTrials.gov) | October 2010 | 25/8/2010 | Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS) | Lipoic Acid for Neuroprotection in Secondary Progressive MS | Multiple Sclerosis, Chronic Progressive | Drug: lipoic acid;Drug: Placebo | VA Office of Research and Development | Oregon Health and Science University | Completed | 40 Years | 70 Years | All | 54 | Phase 2/Phase 3 | United States |
| 518 | NCT01416155 (ClinicalTrials.gov) | October 2010 | 24/3/2011 | Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis | A Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 97 | Phase 2 | Japan;China |
| 519 | EUCTR2010-020515-37-GB (EUCTR) | 27/09/2010 | 17/08/2010 | Long-term safety and tolerability of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 520 | EUCTR2009-011470-15-PL (EUCTR) | 14/09/2010 | 25/05/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 521 | EUCTR2010-020515-37-DE (EUCTR) | 13/09/2010 | 09/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Trade Name: Gilenya 0,5 mg Hartkapseln Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 522 | EUCTR2009-014392-51-HU (EUCTR) | 02/09/2010 | 02/11/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Poland;Spain;Turkey;Russian Federation;Germany;Italy | ||
| 523 | NCT01116427 (ClinicalTrials.gov) | September 2010 | 3/5/2010 | A Cooperative Clinical Study of Abatacept in Multiple Sclerosis | A Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: abatacept;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 65 Years | All | 65 | Phase 2 | United States;Canada |
| 524 | EUCTR2009-015318-23-HU (EUCTR) | 31/08/2010 | 14/06/2010 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Czech Republic;Hungary;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 525 | NCT01185821 (ClinicalTrials.gov) | August 30, 2010 | 19/8/2010 | Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis | A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BAF312 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 56 Years | All | 185 | Phase 2 | United States;Canada;Finland;Germany;Hungary;Italy;Norway;Poland;Russian Federation;Spain;Switzerland;Turkey |
| 526 | EUCTR2009-011470-15-DE (EUCTR) | 20/08/2010 | 08/04/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 527 | EUCTR2009-011470-15-BG (EUCTR) | 12/08/2010 | 30/04/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | United States;Serbia;Czechia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 528 | EUCTR2009-011470-15-AT (EUCTR) | 03/08/2010 | 28/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 529 | NCT01191996 (ClinicalTrials.gov) | August 2010 | 30/8/2010 | Safety Study of an Immunomodulating Microparticle to Treat Progressive Multiple Sclerosis | A Phase 2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered MIS416 in Patients With Chronic Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Biological: MIS416 | Innate Immunotherapeutics | Primorus Clinical Trials;National Multiple Sclerosis Society | Completed | 18 Years | N/A | Both | 34 | Phase 1/Phase 2 | New Zealand |
| 530 | EUCTR2009-018084-27-GB (EUCTR) | 29/07/2010 | 08/06/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Poland;Croatia;Romania;South Africa;Georgia;Bulgaria;Germany;United States;Estonia;Ukraine;Lithuania;Israel | ||
| 531 | EUCTR2010-019029-32-GR (EUCTR) | 19/07/2010 | 14/07/2010 | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 2 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 532 | EUCTR2009-011470-15-HU (EUCTR) | 08/07/2010 | 01/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden | ||
| 533 | EUCTR2009-012716-40-PL (EUCTR) | 06/07/2010 | 11/01/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 534 | NCT01171209 (ClinicalTrials.gov) | July 2010 | 8/7/2010 | REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients | REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Interferon-beta and human leukocyte Interferon-a | Melinda Magyari | University of Copenhagen | Completed | 18 Years | 55 Years | Both | 10 | Phase 2 | Denmark |
| 535 | EUCTR2009-011470-15-GB (EUCTR) | 22/06/2010 | 29/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Sweden;United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands | ||
| 536 | NCT01156311 (ClinicalTrials.gov) | June 2010 | 1/7/2010 | BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis | An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNß) or Glatiramer Acetate (GA) | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 108 | Phase 2 | United States |
| 537 | EUCTR2009-012716-40-DE (EUCTR) | 28/05/2010 | 16/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | France;Czech Republic;Estonia;Slovakia;Poland;Bulgaria;Germany | ||
| 538 | EUCTR2008-006786-92-FR (EUCTR) | 27/05/2010 | 06/04/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden | ||
| 539 | NCT01093326 (ClinicalTrials.gov) | May 12, 2010 | 24/3/2010 | Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis | Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mg | Actelion | NULL | Active, not recruiting | 18 Years | 55 Years | All | 353 | Phase 2 | United States;Austria;Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Czech Republic;Italy |
| 540 | NCT01006941 (ClinicalTrials.gov) | May 2010 | 7/10/2009 | Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study | Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study | Relapsing Multiple Sclerosis | Biological: Trichuris suis ova | Rigshospitalet, Denmark | University of Copenhagen;Statens Serum Institut;Copenhagen University Hospital, Hvidovre;OvaMed GmbH | Completed | 19 Years | 55 Years | Both | 10 | Phase 2 | Denmark |
| 541 | EUCTR2009-011470-15-CZ (EUCTR) | 30/04/2010 | 29/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 542 | EUCTR2009-011470-15-SE (EUCTR) | 12/04/2010 | 04/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Sweden;Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany | ||
| 543 | EUCTR2009-012716-40-BG (EUCTR) | 01/04/2010 | 08/04/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;France;Estonia;Bulgaria;Poland | ||
| 544 | NCT01051349 (ClinicalTrials.gov) | March 31, 2010 | 15/1/2010 | Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis | A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab);Biological: trivalent seasonal influenza vaccine | Biogen | AbbVie | Completed | 18 Years | 60 Years | All | 410 | Phase 2 | Czechia;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Czech Republic |
| 545 | EUCTR2009-015318-23-GB (EUCTR) | 31/03/2010 | 17/03/2010 | A study designed to determine safety and efficacy of Daclizumab High Yield Process (DAC HYP) in patients with Multiple Sclerosis Who Have Completed Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) - SELECTED | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 546 | EUCTR2009-011470-15-FI (EUCTR) | 30/03/2010 | 09/02/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 547 | EUCTR2009-014339-19-ES (EUCTR) | 18/03/2010 | 20/01/2010 | ESTUDIO DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | ESTUDIO DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE ONO 4641 EN PACIENTES CON ESCLEROSIS MÚLTIPLE REMITENTE-RECURRENTE.A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Esclerosis múltiple remitente-recurrente.Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: ONO-4641 Product Code: ONO-4641 Product Code: ONO-4641 | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 376 | Phase 2 | Czech Republic;Greece;Spain;Germany | ||
| 548 | EUCTR2009-012716-40-CZ (EUCTR) | 10/03/2010 | 08/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 549 | EUCTR2009-012716-40-FR (EUCTR) | 03/03/2010 | 28/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;Estonia;France;Poland | ||
| 550 | EUCTR2009-014392-51-PL (EUCTR) | 03/03/2010 | 23/11/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Spain;Poland;Turkey;Russian Federation;Germany;Italy | ||
| 551 | NCT01081782 (ClinicalTrials.gov) | March 2010 | 4/3/2010 | A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis | A Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ONO-4641;Drug: ONO-4641 placebo | Ono Pharma USA Inc | NULL | Completed | 18 Years | 55 Years | Both | 407 | Phase 2 | United States;Belgium;Canada;Czech Republic;Germany;Greece;Japan;Poland;Russian Federation;Spain;Ukraine |
| 552 | NCT01071083 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | Treatment Interruption of Natalizumab | Randomized Treatment Interruption of Natalizumab | Relapsing Remitting Multiple Sclerosis | Drug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetate | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 60 Years | All | 175 | Phase 2 | United States;Germany;Spain |
| 553 | NCT01077466 (ClinicalTrials.gov) | March 2010 | 26/2/2010 | Natalizumab Treatment of Progressive Multiple Sclerosis | Natalizumab Treatment of Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis | Drug: Natalizumab | Rigshospitalet, Denmark | Copenhagen University Hospital, Hvidovre;Biogen Idec;University of Copenhagen;Signifikans ApS | Completed | 19 Years | 55 Years | Both | 24 | Phase 2 | Denmark |
| 554 | EUCTR2009-014392-51-FI (EUCTR) | 10/02/2010 | 22/12/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Poland;Spain;Turkey;Russian Federation;Germany;Italy | ||
| 555 | EUCTR2009-012716-40-SK (EUCTR) | 03/02/2010 | 19/01/2010 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | France;Czech Republic;Estonia;Slovakia;Poland;Bulgaria;Germany | ||
| 556 | NCT01073813 (ClinicalTrials.gov) | February 2010 | 22/2/2010 | Neuroprotection and Repair in Optic Neuritis | Developing Neuroprotection and Repair Strategies in MS: Phase IIa Randomized, Controlled Trial of Minocycline in Acute Optic Neuritis (ON) | Multiple Sclerosis;Optic Neuritis | Drug: Minocycline | University of Calgary | Neuroscience Canada | Terminated | 18 Years | 60 Years | Both | 6 | Phase 2 | Canada |
| 557 | EUCTR2009-015318-23-CZ (EUCTR) | 21/01/2010 | 03/12/2009 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 558 | EUCTR2007-001496-11-GB (EUCTR) | 15/01/2010 | 15/03/2010 | The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis - Multiple Sclerosis Tetanus Vaccine for Reduction of Inflammation-1 | The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis - Multiple Sclerosis Tetanus Vaccine for Reduction of Inflammation-1 | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple Sclerosis | Trade Name: Revaxis Product Name: Revaxis | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 46 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 559 | EUCTR2009-016703-35-DK (EUCTR) | 08/01/2010 | 27/11/2009 | Natalizumabbehandling af progressiv multipel sklerose - NAPMS | Natalizumabbehandling af progressiv multipel sklerose - NAPMS | Secondary progressive multiple sclerosis and primary progressive multiple sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 12.0;Classification code 10063401;Term: Primary progressive multiple sclerosis | Trade Name: Tysabri Product Name: Natalizumab INN or Proposed INN: NATALIZUMAB Other descriptive name: Tysabri | Dansk Multipel Sclerose Center | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Denmark | ||
| 560 | EUCTR2009-012716-40-EE (EUCTR) | 31/12/2009 | 07/12/2009 | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: PI-2301 Product Code: PI-2301 Product Name: PI-2301 Product Code: PI-2301 Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Peptimmune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Germany;Czech Republic;Bulgaria;France;Estonia;Poland | ||
| 561 | EUCTR2008-004753-14-AT (EUCTR) | 28/12/2009 | 10/11/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ENDORSE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 562 | EUCTR2008-006333-27-GB (EUCTR) | 03/12/2009 | 18/10/2010 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: Interferon beta 1a Other descriptive name: PEGylated Interferon Beta-1a | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand | ||
| 563 | NCT01051817 (ClinicalTrials.gov) | December 2009 | 19/1/2010 | POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler | A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis;RRMS | Drug: AIN457;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 73 | Phase 2 | Czech Republic;Russian Federation;Ukraine;Serbia;Sweden |
| 564 | NCT01039103 (ClinicalTrials.gov) | December 2009 | 20/12/2009 | Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS) | A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Relapsing-remitting Multiple Sclerosis or in Patients With Clinically Isolated Syndrome (CIS) | Acute Exacerbation of Remitting Relapsing Multiple Sclerosis;Clinically Isolated Syndrome | Drug: PEG-liposomal prednisolone sodium phosphate;Drug: Methylprednisolone | Galapagos NV | NULL | Terminated | 18 Years | 65 Years | Both | 15 | Phase 2 | Belgium;Germany;Poland |
| 565 | NCT00986960 (ClinicalTrials.gov) | December 2009 | 29/9/2009 | Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS) | Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study | Multiple Sclerosis | Drug: repository corticotropin injection;Drug: Saline | University at Buffalo | NULL | Terminated | 18 Years | 65 Years | All | 3 | Phase 2 | United States |
| 566 | EUCTR2009-012989-30-GB (EUCTR) | 17/11/2009 | 13/07/2009 | A clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 567 | EUCTR2009-013884-21-BE (EUCTR) | 13/11/2009 | 10/09/2009 | A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) | A randomized, international, multi centre study to assess the efficacy and safety of intravenous PEG-liposomal prednisolone sodium phosphate (Nanocort®) vs intravenous methylprednisolone (Solu-Medrol®) treatment in patients with acute exacerbation of relapsing-remitting Multiple Sclerosis or in patients with clinically isolated syndrome (CIS) | Patients with acute exacerbation of Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PEG-liposomal Prednisolone Sodium Phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Trade Name: Solu-Medrol INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Enceladus Pharmaceuticals BV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Poland;Belgium;Germany | ||
| 568 | NCT01615887 (ClinicalTrials.gov) | November 2009 | 23/3/2011 | Study of Lisdexamfetamine Sulfate to Treat Cognitive Dysfunction in Multiple Sclerosis | Effects of Lisdexamfetamine on Bradyphrenia in Multiple Sclerosis | Multiple Sclerosis | Drug: lisdexamfetamine sulfate;Drug: placebo | State University of New York at Buffalo | NULL | Completed | 18 Years | 55 Years | Both | 63 | Phase 2 | United States |
| 569 | NCT01198132 (ClinicalTrials.gov) | November 2009 | 8/9/2010 | A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly | A Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly | Multiple Sclerosis | Dietary Supplement: Cholecalciferol (Vitamin D3);Dietary Supplement: Placebo;Drug: Rebif | Merck KGaA | Merck Serono S.A.S, France | Completed | 18 Years | 65 Years | All | 129 | Phase 2 | France |
| 570 | NCT01144117 (ClinicalTrials.gov) | November 2009 | 7/6/2010 | The Effects of Erythropoietin on Clinical Disability and Brain Pathology in Patients With Progressive Multiple Sclerosis | Double Blind, Placebo-controlled Study to Assess the Effects of Erythropoietin on Clinical Disability and Brain Pathology as Shown by Magnetic Resonance Imaging in Patients With Progressive Multiple Sclerosis | Multiple Sclerosis (Primary or Secondary Progressive Phase). | Drug: Erythropoietin | Rigshospitalet, Denmark | Danish Research Centre for Magnetic Resonance | Recruiting | 19 Years | 60 Years | Both | 56 | Phase 2 | Denmark |
| 571 | NCT01719159 (ClinicalTrials.gov) | November 2009 | 25/10/2012 | Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis | Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: Rituximab | Anders Svenningsson | Västerbotten County Council, Sweden | Completed | 18 Years | 65 Years | Both | 23 | Phase 2 | Sweden |
| 572 | NCT01037907 (ClinicalTrials.gov) | November 2009 | 21/12/2009 | A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS | Relapsing Remitting Multiple Sclerosis | Drug: Pleneva TM BGC20-0134;Drug: Placebo | Boston Scientific Corporation | NULL | Terminated | 18 Years | 65 Years | All | 173 | Phase 2 | Belgium;France;Germany;Poland;Russian Federation;Spain;Italy |
| 573 | EUCTR2009-011585-28-ES (EUCTR) | 30/10/2009 | 24/08/2009 | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)Estudio fase IIa, aleatorizado, doble ciego, controlado con placebo, de BGC20-0134 administrado de forma oral en pacientes con esclerosis múltiple recurrente remitente (EMRR)? | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS)Estudio fase IIa, aleatorizado, doble ciego, controlado con placebo, de BGC20-0134 administrado de forma oral en pacientes con esclerosis múltiple recurrente remitente (EMRR)? | Esclerosis Múltiple Recurrente-RemitenteRelapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BGC20-0134 Product Code: BGC20-0134 Other descriptive name: Glicerol-1,3-didecanoato-2-octadeca-(6Z,9Z,12Z)-trienoato | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 166 | Phase 2 | Germany;Belgium;France;Spain | ||
| 574 | EUCTR2009-011626-34-SE (EUCTR) | 28/10/2009 | 20/07/2009 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis - B2201 | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | Czech Republic;Sweden | ||
| 575 | EUCTR2008-006786-92-BE (EUCTR) | 22/10/2009 | 24/09/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple scelorsis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Netherlands;Sweden | ||
| 576 | EUCTR2009-011585-28-FR (EUCTR) | 21/10/2009 | 05/08/2009 | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | Germany;Belgium;France;Spain | ||
| 577 | EUCTR2008-005021-11-BE (EUCTR) | 14/10/2009 | 12/12/2008 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 68 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 578 | EUCTR2009-011585-28-DE (EUCTR) | 08/10/2009 | 07/07/2009 | Early phase clinical trial to evaluate the effectiveness and safety of a new orally administered drug in patients with relapsing-remitting multiple sclerosis | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase 2 | France;European Union;Spain;Belgium;Russian Federation;Germany | ||
| 579 | NCT01006265 (ClinicalTrials.gov) | October 1, 2009 | 30/10/2009 | Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis | Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: ACT-128800 Dose 1;Drug: Placebo;Drug: ACT-128800 Dose 2;Drug: ACT-128800 Dose 3 | Actelion | NULL | Completed | 18 Years | 55 Years | All | 464 | Phase 2 | Bulgaria;Canada;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Australia;Austria;Belgium;United States;Czech Republic |
| 580 | NCT00947895 (ClinicalTrials.gov) | October 2009 | 2/7/2009 | Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone | Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Study | Multiple Sclerosis | Drug: Methylprednisolone;Drug: ACTH;Other: IV placebo;Other: IM placebo | Neurologique Foundation, Inc. | Mallinckrodt | Terminated | 18 Years | N/A | Both | 30 | Phase 2/Phase 3 | United States |
| 581 | EUCTR2009-011585-28-BE (EUCTR) | 28/09/2009 | 13/07/2009 | Early phase clinical trial to evaluate the effectiveness and safety of a new orally administered drug in patients with relapsing-remitting multiple sclerosis | A randomised double-blind placebo-controlled phase IIa study of orally administered BGC20-0134 in patients with relapsing-remitting multiple sclerosis (RRMS) | relapsing-remitting multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: BCG20-0134 Product Code: BCG20-0134 Other descriptive name: Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate | BTG International Ltd | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase 2 | France;European Union;Spain;Belgium;Russian Federation;Germany | ||
| 582 | EUCTR2008-004753-14-FR (EUCTR) | 18/09/2009 | 06/08/2009 | A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: BG00012 Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands | ||
| 583 | NCT00981084 (ClinicalTrials.gov) | September 2009 | 18/9/2009 | Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS) | The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study | Multiple Sclerosis | Drug: armodafinil | University of Missouri, Kansas City | University of Kansas | Completed | 18 Years | 60 Years | All | 33 | Phase 2/Phase 3 | United States |
| 584 | EUCTR2008-004753-14-LV (EUCTR) | 13/08/2009 | 03/06/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ENDORSE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 585 | EUCTR2008-008719-25-FI (EUCTR) | 13/08/2009 | 19/02/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Name: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy | ||
| 586 | EUCTR2008-005021-11-SE (EUCTR) | 12/08/2009 | 13/05/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 587 | EUCTR2008-005021-11-CZ (EUCTR) | 22/07/2009 | 08/06/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | France;Czech Republic;Belgium;Sweden | ||
| 588 | EUCTR2008-006786-92-ES (EUCTR) | 04/07/2009 | 06/05/2009 | Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitente | Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, seguridad y tolerabilidad de tres dosis de ACT-128800, un agonista oral de los receptores S1P1, durante 24 semanas en pacientes con esclerosis múltiple recurrente-remitente | Esclerosis Múltiple Recurrente-Remitente MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden | ||
| 589 | EUCTR2008-002626-11-SE (EUCTR) | 02/07/2009 | 24/04/2009 | Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis | Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSIT | Severe progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Mabthera Other descriptive name: RITUXIMAB | Dept of Neurology | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 590 | EUCTR2008-007459-28-FR (EUCTR) | 01/07/2009 | 15/05/2009 | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: N/a Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany | ||
| 591 | EUCTR2009-010788-18-GB (EUCTR) | 01/07/2009 | 13/07/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A. | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 592 | EUCTR2008-006786-92-CZ (EUCTR) | 18/06/2009 | 26/03/2009 | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 2 | Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Sweden | ||
| 593 | EUCTR2008-003706-33-GB (EUCTR) | 09/06/2009 | 27/11/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 594 | EUCTR2008-007549-29-DK (EUCTR) | 09/06/2009 | 06/05/2009 | Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS A | Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS A | Relapsing Multipel Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 12.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 12.0;Classification code 10053395;Term: Progressive multiple sclerosis | Product Name: Trichuris suis Ova Product Code: TSO INN or Proposed INN: Trichuris suis eggs Other descriptive name: Trichuris suis eggs | Danish Multiple Sclerosis Research Center | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Denmark | ||
| 595 | NCT00917839 (ClinicalTrials.gov) | June 2009 | 9/6/2009 | The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis | Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis. | Relapsing-Remitting Multiple Sclerosis | Drug: lamotrigine | Cantonal Hospital of St. Gallen | NULL | Recruiting | 18 Years | 50 Years | Both | 88 | Phase 2 | Switzerland |
| 596 | EUCTR2009-011516-37-DK (EUCTR) | 29/05/2009 | 15/05/2009 | Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS | Double blind, placebo-controlled study to assess the effects of Erythropoietin on clinical disability and brain pathology as shown by magnetic resonance imaging in patients with progressive multiple sclerosis - EPO-ProgMS | Multiple Sclerosis, with primary and secondary progressive courses. MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: NeoRecormon INN or Proposed INN: Solu-Medrol Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Danish Multiple Sclerosis Research Centre | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 597 | EUCTR2008-005021-11-FR (EUCTR) | 26/05/2009 | 24/03/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | France;Czech Republic;Belgium;Sweden | ||
| 598 | EUCTR2008-005559-46-GB (EUCTR) | 18/05/2009 | 27/07/2010 | An Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis who have completed Treatment in the study 205MS201 (SELECT) | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) - SELECTION | Relapsing-remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 599 | EUCTR2008-008719-25-HU (EUCTR) | 12/05/2009 | 11/03/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Finland;Hungary;Germany;Spain;Italy | ||
| 600 | EUCTR2007-002627-32-GB (EUCTR) | 05/05/2009 | 18/04/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - Efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 601 | NCT00799942 (ClinicalTrials.gov) | May 2009 | 27/11/2008 | Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus | Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus | Nystagmus, Congenital;Nystagmus, Acquired;Multiple Sclerosis | Drug: Neramexane mesylate | Merz Pharmaceuticals GmbH | NULL | Terminated | 18 Years | 81 Years | Both | 48 | Phase 2 | United Kingdom |
| 602 | NCT00799890 (ClinicalTrials.gov) | May 2009 | 28/11/2008 | Sunphenon in Progressive Forms of Multiple Sclerosis | Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Sunphenon EGCG;Drug: Placebo | Friedemann Paul | TAIYO EUROPE | Completed | 18 Years | 65 Years | All | 61 | Phase 2/Phase 3 | Germany |
| 603 | NCT01228396 (ClinicalTrials.gov) | May 2009 | 26/9/2010 | AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis | A Randomised, Double-blind, Placebo-controlled Study of AIMSPRO in Treating Bladder Dysfunction in Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: Hyperimmune caprine serum against HIV lysate | Daval International Limited | NULL | Active, not recruiting | 18 Years | N/A | Both | 20 | Phase 2 | United Kingdom |
| 604 | EUCTR2008-008719-25-IT (EUCTR) | 08/04/2009 | 06/03/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsingremitting multiple sclerosis - ND | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsingremitting multiple sclerosis - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy | ||
| 605 | NCT00914290 (ClinicalTrials.gov) | April 2009 | 2/6/2009 | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis | Spasticity;Multiple Sclerosis | Drug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IR | Impax Laboratories, LLC | NULL | Completed | 18 Years | N/A | All | 23 | Phase 2 | United States |
| 606 | NCT00882999 (ClinicalTrials.gov) | April 2009 | 16/4/2009 | A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: LY2127399;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 64 Years | All | 245 | Phase 2 | United States;Bulgaria;Czechia;France;Germany;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;Belgium;Canada;Czech Republic;Denmark;Finland;Switzerland |
| 607 | NCT00879658 (ClinicalTrials.gov) | March 30, 2009 | 9/4/2009 | Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis | A Phase II, Double-blind, Randomized, Multi-center, Adaptive Dose-ranging, Placebo-controlled, Parallel-group Study Evaluating Safety, Tolerability and Efficacy on MRI Lesion Parameters and Determining the Dose Response Curve of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis. | Relapsing-remitting Multiple Sclerosis | Drug: BAF312;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 297 | Phase 2 | United States;Canada;Finland;Germany;Hungary;Italy;Norway;Poland;Russian Federation;Spain;Switzerland;Turkey |
| 608 | EUCTR2008-001999-67-FR (EUCTR) | 16/03/2009 | 03/02/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Phase 2 | France;Finland;Spain;Germany | ||
| 609 | EUCTR2008-004753-14-CZ (EUCTR) | 16/03/2009 | 22/01/2009 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ENDORSE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 610 | NCT00853762 (ClinicalTrials.gov) | March 2009 | 26/2/2009 | Atacicept in Multiple Sclerosis Extension Study, Phase II | An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension) | Relapsing Multiple Sclerosis | Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg | EMD Serono | Merck KGaA | Terminated | 18 Years | 60 Years | All | 74 | Phase 2 | United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 611 | EUCTR2008-000256-26-GB (EUCTR) | 16/02/2009 | 08/12/2010 | An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1a | An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1a | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Mitoxantrone Product Name: Mitoxantrone Product Code: PL 04515/0127 Trade Name: Rebif® INN or Proposed INN: Mitoxantrone | Queen Mary, University of London | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | United Kingdom | ||
| 612 | NCT00870740 (ClinicalTrials.gov) | February 2009 | 26/3/2009 | Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 517 | Phase 2 | Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom |
| 613 | EUCTR2008-001999-67-ES (EUCTR) | 30/01/2009 | 17/11/2008 | Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Esclerosis Múltiple______________Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Phase 2 | France;Finland;Spain;Germany | ||
| 614 | EUCTR2008-004753-14-BE (EUCTR) | 22/01/2009 | 23/12/2008 | Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis | A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ENDORSE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BG00012 Product Code: BG00012 INN or Proposed INN: Dimethyl Fumarate Other descriptive name: DIMETHYL FUMARATE | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1738 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand | ||
| 615 | EUCTR2007-004223-38-GB (EUCTR) | 05/01/2009 | 26/11/2007 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline UK | NULL | Not Recruiting | Female: yes Male: yes | 57 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 616 | NCT00841321 (ClinicalTrials.gov) | January 2009 | 9/2/2009 | Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis | Ginkgo Biloba for Cognitive Impairment in Multiple Sclerosis | Multiple Sclerosis;Cognitive Ability, General | Drug: Ginkgo biloba;Drug: Placebo | VA Office of Research and Development | NULL | Completed | 18 Years | 65 Years | All | 120 | Phase 2 | United States |
| 617 | NCT00811902 (ClinicalTrials.gov) | December 2008 | 18/12/2008 | Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis. | Multiple Sclerosis | Drug: Nerispirdine (HP184);Drug: placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 405 | Phase 2 | United States;Canada;Finland;France;Germany;Norway;Spain |
| 618 | EUCTR2006-003366-33-IT (EUCTR) | 30/10/2008 | 08/01/2008 | A phase II, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif New Formulation in Multiple Scleroris Subjects with Active Disease - Phase II Cladribine add-on to Rebif New Formulation in MS subjects with active disease | A phase II, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif New Formulation in Multiple Scleroris Subjects with Active Disease - Phase II Cladribine add-on to Rebif New Formulation in MS subjects with active disease | MULTIPLE SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: REBIF*SC 12SIR 12000000UI44MCG INN or Proposed INN: Cladribine | MERCK SERONO INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Spain;Italy | ||
| 619 | EUCTR2007-006338-32-FI (EUCTR) | 08/10/2008 | 30/06/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 620 | EUCTR2007-006338-32-BG (EUCTR) | 07/10/2008 | 31/07/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Multiple sclerosis is a disabling disease of brain and spinal cord thatdisrupts flow of information within brain, characterized by flare-ups withperiods of remission in between (relapsing remitting) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: oclelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 621 | EUCTR2007-006338-32-BE (EUCTR) | 15/09/2008 | 17/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 622 | EUCTR2007-006338-32-IT (EUCTR) | 11/09/2008 | 02/10/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI. | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS. | Relapsing-Remitting Multiple Sclerosis (RRMS). MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Denmark;Bulgaria;Netherlands;Germany | ||
| 623 | NCT00772525 (ClinicalTrials.gov) | September 2008 | 13/10/2008 | Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis | A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis | Multiple Sclerosis;Optic Nerve;Neuritis | Drug: Nerispirdine (HP184);Drug: Placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 31 | Phase 2 | United States |
| 624 | EUCTR2007-003936-50-GB (EUCTR) | 11/08/2008 | 13/01/2009 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: atacicept Product Code: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | Netherlands;France;Austria;Lithuania;Australia;Sweden;United Kingdom;Russian Federation;Czech Republic;Canada;Ukraine;Spain;Lebanon;United States | ||
| 625 | EUCTR2007-006338-32-GB (EUCTR) | 28/07/2008 | 07/03/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 626 | NCT00676715 (ClinicalTrials.gov) | July 17, 2008 | 9/5/2008 | A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS | Multiple Sclerosis, Relapsing-Remitting | Drug: Placebo;Drug: Ocrelizumab;Drug: Avonex | Genentech, Inc. | Roche Pharma AG | Active, not recruiting | 18 Years | 55 Years | All | 220 | Phase 2 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Italy;Mexico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands |
| 627 | EUCTR2007-006338-32-ES (EUCTR) | 16/07/2008 | 28/03/2008 | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom | ||
| 628 | EUCTR2007-003936-50-LT (EUCTR) | 15/07/2008 | 20/05/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept Product Code: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA-Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Sweden;Lithuania | ||
| 629 | EUCTR2007-006338-32-NL (EUCTR) | 09/07/2008 | 29/05/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 630 | EUCTR2007-006338-32-DE (EUCTR) | 09/07/2008 | 17/03/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrrelizumab 300 mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrrelizumab 300 mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F. Hoffman-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 631 | EUCTR2007-006338-32-DK (EUCTR) | 09/07/2008 | 09/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 632 | EUCTR2007-003936-50-AT (EUCTR) | 02/07/2008 | 10/03/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 633 | EUCTR2007-003936-50-CZ (EUCTR) | 23/06/2008 | 07/04/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 634 | EUCTR2007-006338-32-SK (EUCTR) | 16/06/2008 | 09/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;United States;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 635 | EUCTR2007-004223-38-DE (EUCTR) | 02/06/2008 | 24/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 2 | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 636 | NCT00716066 (ClinicalTrials.gov) | June 2008 | 15/7/2008 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation | Fred Hutchinson Cancer Center | NULL | Recruiting | N/A | 71 Years | All | 80 | Phase 2 | United States |
| 637 | EUCTR2007-006338-32-CZ (EUCTR) | 28/05/2008 | 01/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 638 | EUCTR2007-003936-50-NL (EUCTR) | 17/05/2008 | 22/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 332 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 639 | EUCTR2007-006338-32-FR (EUCTR) | 06/05/2008 | 26/02/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom | ||
| 640 | NCT00640328 (ClinicalTrials.gov) | May 2008 | 18/3/2008 | Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | A Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) Patients | Multiple Sclerosis | Drug: Ofatumumab 100;Drug: Ofatumumab 300;Drug: Ofatumumab 700;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 38 | Phase 2 | Belgium;Czech Republic;Denmark;Former Serbia and Montenegro;Germany;Poland;Serbia;Sweden;United Kingdom |
| 641 | EUCTR2007-003936-50-SE (EUCTR) | 02/04/2008 | 03/03/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono Geneva- an affiliate of Merck KGaA, Darmstadt Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 642 | NCT00670449 (ClinicalTrials.gov) | April 2008 | 28/4/2008 | An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis | An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 143 | Phase 2 | Japan |
| 643 | NCT00642902 (ClinicalTrials.gov) | April 2008 | 21/3/2008 | A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) | A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course | Relapsing Multiple Sclerosis | Drug: Atacicept;Drug: Placebo matched to atacicept | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 255 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 644 | EUCTR2007-003936-50-BE (EUCTR) | 17/03/2008 | 23/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | France;Czech Republic;Spain;Belgium;Lithuania;Austria;Netherlands;United Kingdom;Sweden | ||
| 645 | EUCTR2007-003936-50-ES (EUCTR) | 10/03/2008 | 02/01/2008 | Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Esclerosis múltiple recidivante Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 332 | Phase 2 | France;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;United Kingdom;Sweden | ||
| 646 | EUCTR2007-000381-20-GB (EUCTR) | 04/03/2008 | 26/11/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 647 | EUCTR2007-003936-50-FR (EUCTR) | 03/03/2008 | 17/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 332 | Phase 2 | France;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;United Kingdom;Sweden | ||
| 648 | NCT01432704 (ClinicalTrials.gov) | March 2008 | 16/8/2011 | Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) | Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS | Multiple Sclerosis | Drug: colecalciferol | University of Turku | Bayer | Completed | 18 Years | 50 Years | Both | 70 | Phase 2/Phase 3 | NULL |
| 649 | EUCTR2008-000490-37-IT (EUCTR) | 26/02/2008 | 20/03/2008 | Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - ND | Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028053;Term: MS | Trade Name: EBIXA INN or Proposed INN: Memantine | OSPEDALE S. RAFFAELE | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Italy | ||
| 650 | EUCTR2005-000365-19-GB (EUCTR) | 19/02/2008 | 11/11/2005 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - CFTY720D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - CFTY720D2301 | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Hungary;Czech Republic;Slovakia;Greece;Finland;Ireland;Lithuania;Germany;United Kingdom;Sweden | ||
| 651 | EUCTR2005-002305-23-GB (EUCTR) | 05/02/2008 | 14/01/2008 | A pilot study of combination monoclonal antibody treatment in early active relapsing-remitting multiple sclerosis using Campath-1H and its non-binding form, SM3. - SM3 | A pilot study of combination monoclonal antibody treatment in early active relapsing-remitting multiple sclerosis using Campath-1H and its non-binding form, SM3. - SM3 | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab | R&D Addenbrookes Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 652 | EUCTR2004-000555-42-GB (EUCTR) | 05/02/2008 | 03/03/2005 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;Italy;United Kingdom;Sweden | ||
| 653 | NCT00390221 (ClinicalTrials.gov) | February 2008 | 17/10/2006 | Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 621 | Phase 2 | Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Australia;Former Serbia and Montenegro;Sweden;Turkey |
| 654 | NCT00630383 (ClinicalTrials.gov) | February 2008 | 27/2/2008 | Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis. | Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis. | Multiple Sclerosis | Biological: Live Hookworm Larvae;Other: Histamine | University of Nottingham | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 2 | United Kingdom |
| 655 | EUCTR2006-005910-11-GB (EUCTR) | 09/01/2008 | 14/08/2007 | A two-phase, Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | A two-phase, Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study. | Spasticity in multiple sclerosis (MS) | Trade Name: Sativex Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 656 | EUCTR2006-006872-39-GB (EUCTR) | 04/01/2008 | 19/06/2007 | A randomised, double-blind, placebo controlled study of AIMSPRO in Multiple Sclerosis - AIMSPRO in MS bladder function | A randomised, double-blind, placebo controlled study of AIMSPRO in Multiple Sclerosis - AIMSPRO in MS bladder function | Overactive Bladder in Secondary Progressive Multiple Sclerosis and the other neurological symptoms associated with Secondary Progressive Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10059617;Term: Overactive bladder MedDRA version: 9.1;Classification code 10012547;Term: Detrusor hyperreflexia | Product Name: AIMSPRO | Daval International Limited | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 657 | NCT00647348 (ClinicalTrials.gov) | January 2008 | 26/3/2008 | Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis | A Phase II Randomised, Placebo-controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis. | Secondary Progressive Multiple Sclerosis | Drug: Simvastatin;Drug: Placebo | Imperial College London | NULL | Completed | 18 Years | 65 Years | All | 140 | Phase 2 | United Kingdom |
| 658 | EUCTR2007-001162-32-GB (EUCTR) | 24/12/2007 | 04/10/2007 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 659 | EUCTR2007-000586-38-IT (EUCTR) | 21/12/2007 | 10/01/2008 | HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND | HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND | PATIENTS AFFECTED BY MULTIPLE SCLEROSIS MedDRA version: 6.1;Level: HLT;Classification code 10052785 | Trade Name: THIOPLEX INN or Proposed INN: Thiotepa Trade Name: ENDOXAN BAXTER INN or Proposed INN: Cyclophosphamide Trade Name: NEUPOGEN INN or Proposed INN: Filgrastim | OSPEDALE S. RAFFAELE | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Italy | ||
| 660 | NCT00623415 (ClinicalTrials.gov) | December 2007 | 15/2/2008 | Flupirtine as Oral Treatment in Multiple Sclerosis | Multicentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-ß1b on Neurodegeneration in Patients With Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Flupirtine;Drug: Placebo | Charite University, Berlin, Germany | Bayer | Terminated | 18 Years | 60 Years | All | 30 | Phase 2 | Germany |
| 661 | NCT00595920 (ClinicalTrials.gov) | November 2007 | 3/1/2008 | Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis | An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00 | Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated Syndrome | Biological: Tovaxin | Opexa Therapeutics, Inc. | NULL | Terminated | N/A | N/A | All | 116 | Phase 2 | United States |
| 662 | NCT00688948 (ClinicalTrials.gov) | November 2007 | 30/5/2008 | Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS) | A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis | Multiple Sclerosis;Bladder Dysfunction | Drug: Alfuzosin | Capital District Health Authority, Canada | Sanofi | Terminated | 18 Years | N/A | Both | 20 | Phase 2/Phase 3 | Canada |
| 663 | EUCTR2006-002204-33-HU (EUCTR) | 29/10/2007 | 22/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Finland;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 664 | EUCTR2006-001152-12-GB (EUCTR) | 24/10/2007 | 14/10/2010 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | ||
| 665 | NCT00104143 (ClinicalTrials.gov) | October 2007 | 23/2/2005 | A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis. | Multiple Sclerosis | Drug: A4I Antagonist | Hoffmann-La Roche | NULL | Withdrawn | 18 Years | 59 Years | Both | 0 | Phase 2 | Bulgaria;Canada;Czech Republic;Germany;Poland;Russian Federation;Slovakia;Spain;United Kingdom;Finland;United States |
| 666 | NCT00811395 (ClinicalTrials.gov) | October 2007 | 18/12/2008 | Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA] | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 182 | Phase 2 | United States;Austria;Canada;Germany;Italy;Spain;United Kingdom |
| 667 | EUCTR2007-001031-63-CZ (EUCTR) | 20/09/2007 | 10/08/2007 | AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis. | AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis. | Spasticity associated with multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028335;Term: Muscle spasticity | Trade Name: Tolposan Product Code: AV605 INN or Proposed INN: Tolperisone HC1 Other descriptive name: Tolpersan | Avigen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Czech Republic;Germany | ||
| 668 | EUCTR2006-006347-31-GB (EUCTR) | 06/09/2007 | 07/08/2007 | A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis | A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis | Multiple Sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive | Product Name: Encapsulated Simvastatin tablets Product Code: MSTC-001 (MS-STAT) | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 669 | NCT00638833 (ClinicalTrials.gov) | September 2007 | 12/3/2008 | Memantine Therapy for Multiple Sclerosis | Pilot Clinical Trial With Memantine for Cognitive Deficits in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Memantine;Drug: Placebo | Clinica Universidad de Navarra, Universidad de Navarra | H. Lundbeck A/S | Terminated | 18 Years | 65 Years | Both | 20 | Phase 2 | Spain |
| 670 | NCT00532532 (ClinicalTrials.gov) | September 2007 | 18/9/2007 | Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis | AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis | Muscle Spasticity | Drug: tolperisone HCl | Avigen | NULL | Terminated | 18 Years | 70 Years | Both | 150 | Phase 2 | Czech Republic;Germany;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro |
| 671 | NCT00537082 (ClinicalTrials.gov) | September 2007 | 26/9/2007 | Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS) | A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 171 | Phase 2 | Japan |
| 672 | EUCTR2006-002204-33-DE (EUCTR) | 29/08/2007 | 12/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Netherlands;Germany;United Kingdom;Sweden | ||
| 673 | EUCTR2006-004893-29-GB (EUCTR) | 25/07/2007 | 17/12/2006 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Austria;Germany;Italy;United Kingdom | ||
| 674 | EUCTR2006-002204-33-FR (EUCTR) | 18/07/2007 | 26/03/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 675 | EUCTR2006-002633-20-FR (EUCTR) | 04/07/2007 | 11/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 676 | NCT00469378 (ClinicalTrials.gov) | July 2007 | 2/5/2007 | Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple Sclerosis | An Open-label Study of Leukocyte Counts in the Cerebrospinal Fluid and Blood of Subjects With Relapsing Forms of Multiple Sclerosis Following Treatment With Firategrast | Multiple Sclerosis | Drug: firategrast | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 46 | Phase 2 | Belgium;Czech Republic;Denmark;Norway;Sweden |
| 677 | EUCTR2006-002204-33-GB (EUCTR) | 18/06/2007 | 26/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 678 | EUCTR2006-005262-39-DE (EUCTR) | 30/05/2007 | 09/03/2007 | Flupirtin as Oral Treatment in MS - FLORIMS | Flupirtin as Oral Treatment in MS - FLORIMS | Relapsing-remitting multiple sclerosis | Trade Name: Trancopal Dolo Product Name: Flupirtin INN or Proposed INN: Flupirtin Other descriptive name: Flupirtinmaleat | Charité-Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Germany | ||
| 679 | EUCTR2004-004519-43-DE (EUCTR) | 29/05/2007 | 09/02/2007 | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Product Code: RO0506997 Product Code: RO0506997 Product Code: RO0506997 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United Kingdom;Czech Republic;Germany;Spain | ||
| 680 | EUCTR2006-002204-33-ES (EUCTR) | 04/05/2007 | 05/03/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas. | Relapsing forms of multiple slerosisEsclerosis multiple (EM) con recaidas MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | France;Hungary;Finland;Belgium;Spain;Netherlands;Germany;United Kingdom;Sweden | ||
| 681 | EUCTR2006-007057-42-CZ (EUCTR) | 03/05/2007 | 16/03/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Belgium;Denmark;Sweden | ||
| 682 | NCT00489489 (ClinicalTrials.gov) | May 2007 | 20/6/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-beta in Subjects With Multiple Sclerosis. | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for Teriflunomide);Drug: Interferon-ß | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 118 | Phase 2 | United States;Canada;Germany;Italy;Spain;Poland |
| 683 | NCT00484536 (ClinicalTrials.gov) | May 2007 | 8/6/2007 | Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323 | Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323. | Multiple Sclerosis | Drug: CDP323;Drug: placebo | UCB Pharma | Biogen Idec | Terminated | 18 Years | 55 Years | Both | 232 | Phase 2 | United States;Belgium;Canada;Finland;France;Germany;Hungary;Netherlands;Spain;Sweden;United Kingdom |
| 684 | EUCTR2006-005270-47-FI (EUCTR) | 23/04/2007 | 19/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 685 | EUCTR2006-002204-33-SE (EUCTR) | 20/04/2007 | 26/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 686 | EUCTR2006-002204-33-NL (EUCTR) | 16/04/2007 | 31/10/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 687 | EUCTR2006-005270-47-ES (EUCTR) | 08/04/2007 | 05/02/2007 | Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up | Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up | Esclerosis Múltiple Recidivante | Trade Name: Betaferon 250 microgramos INN or Proposed INN: Interferon beta 1b Product Name: Betaferon 500 µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta 1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 688 | EUCTR2006-002204-33-FI (EUCTR) | 05/04/2007 | 20/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 689 | NCT00475865 (ClinicalTrials.gov) | April 2007 | 18/5/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 123 | Phase 2 | United States;Austria;Canada;Germany;Italy;United Kingdom |
| 690 | EUCTR2004-004519-43-SK (EUCTR) | 20/03/2007 | 13/02/2007 | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Product Code: RO0506997 Product Code: RO0506997 Product Code: RO0506997 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Czech Republic;Slovakia;Spain;Germany;United Kingdom | ||
| 691 | EUCTR2004-004519-43-GB (EUCTR) | 07/03/2007 | 08/07/2005 | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Product Code: RO0506997 Product Code: RO0506997 Product Code: RO0506997 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Germany;Czech Republic;United Kingdom;Spain | ||
| 692 | EUCTR2006-002204-33-BE (EUCTR) | 02/03/2007 | 08/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 693 | NCT01111656 (ClinicalTrials.gov) | March 2007 | 15/3/2010 | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b | SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study (SWABIMS Follow Up-study) | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b group;Drug: Interferon beta-1b/Atorvastatin group | University Hospital Inselspital, Berne | Viollier AG, Basel, Switzerland;PharmaPart GmbH, Thalwil, Switzerland | Completed | 18 Years | 67 Years | Both | 28 | Phase 2 | Switzerland |
| 694 | NCT00451204 (ClinicalTrials.gov) | March 2007 | 22/3/2007 | A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS) | A Combination Trial of Copaxone Plus Estriol in RRMS | Relapsing Remitting Multiple Sclerosis | Drug: Estriol;Drug: Placebo;Drug: Copaxone | University of California, Los Angeles | Washington University School of Medicine;University of Texas Southwestern Medical Center;Ohio State University;University of Medicine and Dentistry of New Jersey;University of Chicago;University of Utah;Johns Hopkins University;University of Kansas Medical Center;University of Minnesota, MN;Mayo Clinic;University of Colorado, Aurora;University of New Mexico;University of Pennsylvania;Dartmouth-Hitchcock Medical Center;National Multiple Sclerosis Society;National Institutes of Health (NIH);National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 50 Years | Female | 158 | Phase 2 | United States;Canada |
| 695 | EUCTR2006-003384-30-SK (EUCTR) | 26/02/2007 | 08/11/2006 | A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for Multiple Sclerosis | A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for Multiple Sclerosis | Multiple Sclerosis | Product Name: NeuroVax 300ug/mL Dose for IM Injection Product Code: IR902 Other descriptive name: VB6S5 Other descriptive name: VB13S1 Other descriptive name: VB5S2 | The Immune Response Corporation | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Slovakia | ||
| 696 | EUCTR2006-003134-14-ES (EUCTR) | 23/02/2007 | 26/10/2009 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | Multiple sclerosis.Esclerosis Múltiple. | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Spain;Germany;Italy | ||
| 697 | EUCTR2006-002856-14-DE (EUCTR) | 21/02/2007 | 07/11/2006 | Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis. | Randomised, placebo-controlled, three-arm parallel-group, double-blind, multicentre, national clinical phase II study to evaluate the efficacy, safety, and tolerability of intravenous 3 and 6 g/m² treosulfan given every 6 weeks in patients with secondary progressive and progressive relapsing multiple sclerosis. | Secondary progressive or progressive relapsing multiple sclerosis with signs of disease activity in terms of inflammation MedDRA version: 8.1;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Trade Name: Ovastat 1000 INN or Proposed INN: TREOSULFAN Trade Name: Ovastat 5000 INN or Proposed INN: TREOSULFAN | medac Gesellschaft für klinische Spezialpräparate mbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
| 698 | EUCTR2006-003366-33-ES (EUCTR) | 13/02/2007 | 03/03/2010 | Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa | Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa | Pacientes con esclerosis múltiple activa MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: not applicable Product Name: Interferon beta-1a FBS-free/HSA free, RNF Product Code: Not applicable Trade Name: not applicable Product Name: cladribina oral Product Code: not applicable INN or Proposed INN: cladribine | Serono International, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Spain;Italy | ||
| 699 | NCT00845338 (ClinicalTrials.gov) | February 2007 | 16/2/2009 | Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity | A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity | Multiple Sclerosis;Overactive Detrusor | Drug: Darifenacin (BAY79-4998) | Bayer | NULL | Terminated | 18 Years | N/A | Both | 7 | Phase 2 | Germany |
| 700 | NCT00870155 (ClinicalTrials.gov) | February 2007 | 26/3/2009 | A Study for Patients With Multiple Sclerosis | An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: dirucotide | Eli Lilly and Company | BioMS Technology Corp. | Terminated | 18 Years | 65 Years | Both | 546 | Phase 2/Phase 3 | Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom |
| 701 | EUCTR2006-002633-20-GB (EUCTR) | 25/01/2007 | 10/02/2012 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 702 | EUCTR2006-003361-14-GB (EUCTR) | 23/01/2007 | 29/09/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 703 | EUCTR2006-004736-79-SK (EUCTR) | 19/01/2007 | 17/10/2006 | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | A double-blind, placebo-controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL 1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis. | To evaluate the efficacy of a selected treatment regimen of ATL 1102 in patients with Relapsing Remitting MS (RRMS) inflammatory lesions using MRI with gadolinium administration compared to placebo. | Product Name: ATL1102 Product Code: ATL1102 | Antisense Therapeutics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Slovakia | ||
| 704 | NCT00457730 (ClinicalTrials.gov) | January 2007 | 4/4/2007 | A Study to Test the Use of Duloxetine for Pain in MS | A Randomized Placebo Controlled Trial of Duloxetine for Central Pain in Multiple Sclerosis | Multiple Sclerosis | Drug: Duloxetine;Drug: Placebo | Brown, Theodore R., M.D., MPH | Eli Lilly and Company | Completed | 18 Years | N/A | All | 38 | Phase 2/Phase 3 | United States |
| 705 | EUCTR2006-002633-20-ES (EUCTR) | 01/12/2006 | 13/04/2012 | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Esclerosis múltiple remitente-recurrente MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline S.A | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Finland;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Norway;New Zealand | ||
| 706 | NCT00395317 (ClinicalTrials.gov) | December 2006 | 1/11/2006 | Study Of SB-683699 Compared To Placebo In Subjects With Relapsing-Remitting Multiple Sclerosis (MS) | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Other: Placebo;Drug: Firategrast 150 mg;Drug: Firategrast 300 mg | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 343 | Phase 2 | Australia;Austria;Canada;Finland;France;Germany;Italy;Netherlands;New Zealand;Norway;Poland;Russian Federation;Spain;United Kingdom;Lithuania |
| 707 | NCT00436826 (ClinicalTrials.gov) | November 30, 2006 | 15/2/2007 | A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD) | A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-ß) Treatment in Multiple Sclerosis Subjects With Active Disease | Multiple Sclerosis | Drug: Cladribine;Drug: Placebo;Drug: Interferon-beta (IFN-beta) | EMD Serono Research & Development Institute, Inc. | NULL | Completed | 18 Years | 65 Years | All | 172 | Phase 2 | United States;Italy;Russian Federation;Spain |
| 708 | NCT00529581 (ClinicalTrials.gov) | November 2006 | 12/9/2007 | A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of C105 in Persons With Multiple Sclerosis With Cognitive Impairment | Cognition Disorders;Multiple Sclerosis | Drug: C105 | Cognition Pharmaceuticals, LLC | NULL | Completed | 18 Years | 65 Years | Both | 150 | Phase 2 | United States |
| 709 | NCT00869986 (ClinicalTrials.gov) | November 2006 | 24/3/2009 | A Study for Patients With Relapsing Remitting Multiple Sclerosis | A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: dirucotide;Drug: placebo | Eli Lilly and Company | BioMS Technology Corp. | Completed | 18 Years | 50 Years | Both | 218 | Phase 2/Phase 3 | Bulgaria;Poland;Russian Federation;Serbia;Slovakia;Ukraine |
| 710 | EUCTR2004-002567-24-GB (EUCTR) | 09/10/2006 | 22/02/2005 | A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable | A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: MLN1202 Product Code: MLN1202 | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Czech Republic;United Kingdom | ||
| 711 | NCT00516893 (ClinicalTrials.gov) | October 2006 | 14/8/2007 | Natalizumab High Titer Immunogenicity and Safety | A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Biological: BG00002-E (natalizumab high titer) | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | All | 113 | Phase 2 | United States |
| 712 | EUCTR2006-001947-70-SK (EUCTR) | 14/09/2006 | 08/08/2006 | A Double Blind, Placebo Controlled Multi-Center Pilot Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis | A Double Blind, Placebo Controlled Multi-Center Pilot Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp. | NULL | Not Recruiting | Female: yes Male: yes | 215 | Phase 2 | Slovakia | ||
| 713 | EUCTR2006-002037-20-ES (EUCTR) | 06/09/2006 | 07/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: Glatiramer acetato Trade Name: Copaxone 20 mg/ml solución para inyección en jeringa precargada Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: GLATIRAMERO ACETATO Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom | ||
| 714 | NCT00588393 (ClinicalTrials.gov) | September 2006 | 22/12/2007 | FolateScan in Autoimmune Disease | Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases | Rheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus Erythematosus | Drug: FolateScan (Technetium Tc 99mEC20) | Mayo Clinic | Endocyte | Completed | 18 Years | N/A | Both | 75 | Phase 2 | United States |
| 715 | EUCTR2006-001161-42-GB (EUCTR) | 29/08/2006 | 15/05/2006 | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 2 | Czech Republic;Hungary;Germany;United Kingdom;Sweden | ||
| 716 | EUCTR2005-005985-35-NL (EUCTR) | 29/08/2006 | 05/07/2006 | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with relapsing forms of Multiple Sclerosis. | Relapsing forms of Multiple Sclerosis MedDRA version: 8.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BIRT 2584 XX Product Code: BIRT 2584 XX | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Czech Republic;Netherlands | ||
| 717 | EUCTR2004-002571-16-ES (EUCTR) | 20/07/2006 | 09/06/2006 | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. | A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. | Secondary progressive multiple sclerosis | Product Name: MBP8298 Synthetic Peptide Product Code: MBP8298 Other descriptive name: MBP8298 Synthetic Peptide | BioMS Technology Corp | NULL | Not Recruiting | Female: yes Male: yes | 553 | Phase 2;Phase 3 | Estonia;Finland;Spain;Lithuania;Denmark;Latvia;Netherlands;United Kingdom;Sweden | ||
| 718 | NCT00288626 (ClinicalTrials.gov) | July 2006 | 7/2/2006 | High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study | A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone;Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM);Procedure: Autologous hematopoietic stem cell transplant | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 60 Years | All | 25 | Phase 2 | United States |
| 719 | NCT00501943 (ClinicalTrials.gov) | July 2006 | 12/7/2007 | Neuroprotection With Riluzole Patients With Early Multiple Sclerosis | Neuroprotection With Riluzole in Patients With Early Multiple Sclerosis | Multiple Sclerosis | Drug: Avonex (Interferon beta 1a);Drug: Riluzole;Drug: Placebo | University of California, San Francisco | National Multiple Sclerosis Society;Oregon Health and Science University | Completed | 18 Years | 55 Years | All | 43 | Phase 2 | United States |
| 720 | EUCTR2005-001567-55-DE (EUCTR) | 23/06/2006 | 29/07/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United Kingdom;Germany;Spain | ||
| 721 | EUCTR2005-004061-41-GB (EUCTR) | 01/06/2006 | 25/10/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI 300 mg concentrate for solution for infusion Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 722 | NCT00342381 (ClinicalTrials.gov) | June 2006 | 20/6/2006 | Fatigue in Multiple Sclerosis: Evaluated With 3 MRI and Transcranial Magnetic Stimulation | Fatigue in Multiple Sclerosis: Evaluated With 3 Tesla MRI and Transcranial Magnetic Stimulation | Multiple Sclerosis;Fatigue | Drug: 3,4-diaminopyridine;Drug: Placebo | University of Aarhus | The Danish Multiple Sclerosis Society | Completed | 18 Years | 55 Years | Both | 120 | Phase 2 | Denmark |
| 723 | NCT00245622 (ClinicalTrials.gov) | May 2006 | 20/10/2005 | Autologous T Cell Vaccine (TCV) for Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS | Relapsing-Remitting Multiple Sclerosis | Biological: Tovaxin Autologous T cell vaccine;Biological: Placebo | Opexa Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 150 | Phase 2 | United States |
| 724 | NCT00324506 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis | A Randomized, Open-label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Mycophenolate Mofetil (CellCept) | University of Texas Southwestern Medical Center | Aspreva Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 43 | Phase 2 | United States |
| 725 | EUCTR2005-005265-11-GB (EUCTR) | 03/04/2006 | 24/02/2006 | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects | A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis. This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects | Relief of central neuropathic pain in subjects with multiple sclerosis (MS) | Product Name: Sativex Product Code: GW-1000-02 Other descriptive name: delta-9-tetrahydrocannabinol Other descriptive name: Cannabidiol | GW Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;United Kingdom | ||
| 726 | EUCTR2005-004334-41-CZ (EUCTR) | 13/02/2006 | 12/01/2006 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Hungary;Czech Republic;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 727 | EUCTR2005-004334-41-GB (EUCTR) | 10/02/2006 | 31/10/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Poland;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 728 | NCT00382629 (ClinicalTrials.gov) | February 2006 | 27/9/2006 | BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis | BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BHT-3009 0.5 mg;Drug: BHT-3009 1.5 mg;Drug: Placebo | Bayhill Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 252 | Phase 2 | NULL |
| 729 | NCT01134627 (ClinicalTrials.gov) | February 2006 | 28/5/2010 | Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS] | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline Versus Placebo as Add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44 Mcg Tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Minocycline;Drug: Placebo | Merck KGaA | NULL | Terminated | 18 Years | 55 Years | All | 305 | Phase 2 | Denmark |
| 730 | EUCTR2005-005263-29-GB (EUCTR) | 31/01/2006 | 09/12/2005 | Multiple Sclerosis and Extract of Cannabis (MUSEC): A randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis. - MUSEC study | Multiple Sclerosis and Extract of Cannabis (MUSEC): A randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in Multiple Sclerosis. - MUSEC study | Multiple Sclerosis | Product Name: Cannador | Gesellschaft fuer klinische Forschung e.V. (Society for Clinical Research) | WELEDA AG | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 731 | EUCTR2005-003903-35-GB (EUCTR) | 19/01/2006 | 19/12/2005 | : The Role of Keppra in the Treatment of Tremor in Multiple Sclerosis | : The Role of Keppra in the Treatment of Tremor in Multiple Sclerosis | Multiple Sclerosis | Trade Name: Keppra 250mg INN or Proposed INN: Levetiracetam Trade Name: Keppra 500mg Product Name: Keppra ® | Newcastle-upon-Tyne Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 732 | EUCTR2005-004334-41-DE (EUCTR) | 11/01/2006 | 21/11/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 733 | EUCTR2005-004334-41-ES (EUCTR) | 04/01/2006 | 10/11/2005 | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 310 | Phase 2 | Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom | ||
| 734 | EUCTR2005-004334-41-HU (EUCTR) | 20/12/2005 | 04/11/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 735 | EUCTR2005-001567-55-GB (EUCTR) | 14/12/2005 | 24/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 736 | NCT00745615 (ClinicalTrials.gov) | December 7, 2005 | 2/9/2008 | An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease | An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL) | Relapsing Remitting Multiple Sclerosis | Drug: Laquinimod;Drug: Placebo | Teva Pharmaceutical Industries, Ltd. | NULL | Terminated | 18 Years | 50 Years | All | 257 | Phase 2 | Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czech Republic |
| 737 | EUCTR2005-004334-41-IT (EUCTR) | 30/11/2005 | 01/03/2006 | An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: ABR-215062 INN or Proposed INN: LAQUINIMOD | Teva Pharmaceutical Industries Ldt | NULL | Not Recruiting | Female: yes Male: yes | 246 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy | ||
| 738 | NCT00273364 (ClinicalTrials.gov) | November 16, 2005 | 5/1/2006 | Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Multiple Sclerosis | Procedure: Hematopoietic Stem Cell Therapy;Drug: Standard treatment with a conventional drug | Northwestern University | Uppsala University;Sheffield Teaching Hospitals NHS Foundation Trust;University of Sao Paulo | Completed | 18 Years | 55 Years | All | 110 | Phase 2 | United States |
| 739 | NCT00270816 (ClinicalTrials.gov) | November 2005 | 27/12/2005 | Interferon ß-1b Treatment by Cyclical Administration | Effect of Cyclical Administration of Interferon ß-1b in Multiple Sclerosis - Comparison With Normal Dose. | Multiple Sclerosis | Drug: Interferon-ß-1b;Drug: Interferon ß-1b | S. Andrea Hospital | Italian Multiple Sclerosis Foundation | Completed | 18 Years | 55 Years | All | 60 | Phase 2/Phase 3 | Italy |
| 740 | NCT00257855 (ClinicalTrials.gov) | November 2005 | 22/11/2005 | A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis | A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis: Single Centre, Phase 2 Trial | Secondary Progressive Multiple Sclerosis | Drug: Lamotrigine | University College London Hospitals | NULL | Completed | 18 Years | 60 Years | Both | 120 | Phase 2 | United Kingdom |
| 741 | EUCTR2004-005148-28-GB (EUCTR) | 28/10/2005 | 20/04/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International, a branch of Laboratoires Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom | ||
| 742 | EUCTR2005-001567-55-ES (EUCTR) | 18/10/2005 | 05/09/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 743 | EUCTR2005-001567-55-AT (EUCTR) | 27/09/2005 | 23/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 744 | EUCTR2005-001340-22-SK (EUCTR) | 27/09/2005 | 29/07/2005 | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS | Multiple sclerosis results from an auto-immune reaction characterized by inflammation within the nervous system. Myelin basic protein is a target of the autoimmune response and is generally regarded as the predominant autoantigen.BHT-3009 is a 3.5 kb bacterial plasmid expression vector containing the coding sequences for full length human myelin basic protein (hMBP). | Product Name: BHT-3009 Product Code: BHT-3009 | Bayhill Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | Czech Republic;Slovakia;Finland;United Kingdom | ||
| 745 | EUCTR2005-001949-42-GB (EUCTR) | 08/09/2005 | 04/07/2005 | A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis | A randomised controlled trial of neuroprotection with lamotrigine in secondary progressive multiple sclerosis - Neuroprotection with lamotrigine in multiple sclerosis | Multiple sclerosis | Product Name: Lamotrigine extended release tablets Product Code: N/A INN or Proposed INN: Lamotrigine Other descriptive name: N/A | University College London | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 746 | NCT00754832 (ClinicalTrials.gov) | September 2005 | 16/9/2008 | American Ginseng Treatment for Multiple Sclerosis Related Fatigue | A Double-blinded, Placebo-controlled Crossover Pilot Study of American Ginseng Treatment for Multiple Sclerosis Related Fatigue | Multiple Sclerosis | Drug: American ginseng extract HT-1001;Drug: placebo | Oregon Health and Science University | National Multiple Sclerosis Society | Completed | 18 Years | 70 Years | All | 56 | Phase 2 | United States |
| 747 | EUCTR2004-004903-39-GB (EUCTR) | 26/07/2005 | 14/06/2005 | A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPT | A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPT | Early, active relapsing remitting Multiple Sclerosis (RRMS) | Trade Name: Mitoxantrone Product Name: Mitoxantrone Trade Name: Copaxone Product Name: Glatiramer Acetate Trade Name: Rebif 44 Product Name: Interferon Beta 1a | The Walton Centre for Neurology and Neurosurgery | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 748 | EUCTR2004-002567-24-HU (EUCTR) | 19/07/2005 | 06/04/2005 | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). | Product Name: MLN1202 Product Code: MLN1202 INN or Proposed INN: Not yet available Other descriptive name: Not yet available | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;United Kingdom;Czech Republic | ||
| 749 | NCT00202423 (ClinicalTrials.gov) | July 2005 | 12/9/2005 | Use of Cannabinoids in Patients With Multiple Sclerosis | fMRI and Neurophysiological Study Protocol on Cannabinoids in Multiple Sclerosis | Multiple Sclerosis | Drug: Sativex | S. Andrea Hospital | University of Roma La Sapienza | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 2 | Italy |
| 750 | NCT00202397 (ClinicalTrials.gov) | June 2005 | 12/9/2005 | Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia | Phase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar Ataxia | Hereditary Ataxia;Multiple Sclerosis;Cerebellar Ataxia | Drug: Riluzole;Other: placebo | S. Andrea Hospital | NULL | Completed | 18 Years | 80 Years | Both | 40 | Phase 2 | Italy |
| 751 | NCT01450488 (ClinicalTrials.gov) | June 2005 | 6/10/2011 | Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis | A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: masitinib | AB Science | NULL | Completed | 18 Years | 60 Years | All | 35 | Phase 2 | NULL |
| 752 | NCT00094172 (ClinicalTrials.gov) | May 2005 | 14/10/2004 | Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin in Patients With Clinically Isolated Syndrome and High Risk of Conversion to Multiple Sclerosis (ITN020AI) | Multiple Sclerosis | Drug: Atorvastatin;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 55 Years | All | 82 | Phase 2 | United States;Canada |
| 753 | NCT00942591 (ClinicalTrials.gov) | May 2005 | 17/7/2009 | Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis. | Multiple Sclerosis | Drug: Interferon beta 1b;Drug: Atorvastatin | University Hospital Inselspital, Berne | CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel | Completed | 18 Years | 55 Years | Both | 77 | Phase 2 | Switzerland |
| 754 | NCT01199640 (ClinicalTrials.gov) | May 2005 | 9/9/2010 | Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis | Multiple Sclerosis | Drug: MLN1202 | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 2 | NULL |
| 755 | EUCTR2004-002567-24-CZ (EUCTR) | 04/04/2005 | 04/02/2005 | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). | Product Name: MLN1202 Product Code: MLN1202 INN or Proposed INN: Not yet available Other descriptive name: Not yet available | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;United Kingdom;Czech Republic | ||
| 756 | NCT00109161 (ClinicalTrials.gov) | April 2005 | 22/4/2005 | Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) | PDL BioPharma, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 270 | Phase 2 | United States;Canada |
| 757 | EUCTR2004-003799-13-GB (EUCTR) | 16/03/2005 | 18/07/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 758 | NCT00349193 (ClinicalTrials.gov) | March 2005 | 26/6/2006 | A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod | A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects | Relapsing Remitting Multiple Sclerosis | Drug: laquinimod 0.3;Drug: laquinimod 0.6;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 306 | Phase 2 | Italy |
| 759 | EUCTR2004-003943-28-GB (EUCTR) | 18/02/2005 | 22/02/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom | ||
| 760 | EUCTR2004-003943-28-ES (EUCTR) | 17/02/2005 | 09/12/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy | ||
| 761 | EUCTR2004-004519-43-CZ (EUCTR) | 12/01/2005 | 04/02/2005 | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Phase II, multicenter, randomised, double-blind, placebo-controlled, parallel group, dose-ranging study to determine the effect on MRI lesions and safety of RO0506997 in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Product Code: RO0506997 Product Code: RO0506997 Product Code: RO0506997 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Germany;United Kingdom;Czech Republic;Spain | ||
| 762 | EUCTR2004-000145-38-GB (EUCTR) | 11/01/2005 | 22/02/2005 | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | Relapse-remitting Multiple Sclerosis (RRMS) Classification code 10048393 | Product Name: Human monoclonal antibody (CNTO 1275) to interleukin-12p40 Product Code: CNTO 1275 Other descriptive name: Anti-IL-12; Human anti-IL-12 Mab; Human anti-IL-12 IgG1 Mab | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Hungary;Czech Republic;United Kingdom | ||
| 763 | EUCTR2004-000145-38-HU (EUCTR) | 14/12/2004 | 28/09/2004 | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | Relapse-remitting Multiple Sclerosis (RRMS) Classification code 10048393 | Product Name: Human monoclonal antibody (CNTO 1275) to interleukin-12p40 Product Code: CNTO 1275 Other descriptive name: Anti-IL-12; Human anti-IL-12 Mab; Human anti-IL-12 IgG1 Mab | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Hungary;United Kingdom;Czech Republic | ||
| 764 | NCT00869726 (ClinicalTrials.gov) | December 2004 | 24/3/2009 | A Study for Patients With Secondary Progressive Multiple Sclerosis | A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Drug: dirucotide;Drug: Placebo | Eli Lilly and Company | BioMS Technology Corp. | Completed | 18 Years | 65 Years | Both | 596 | Phase 2/Phase 3 | Canada;Denmark;Estonia;Finland;Germany;Latvia;Netherlands;Spain;Sweden;United Kingdom |
| 765 | NCT00097188 (ClinicalTrials.gov) | December 2004 | 18/11/2004 | A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: rituximab | Genentech, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 104 | Phase 2 | United States |
| 766 | NCT00360906 (ClinicalTrials.gov) | December 2004 | 4/8/2006 | Omega-3 Fatty Acid Treatment in Multiple Sclerosis | Omega-3 Fatty Acid Treatment in Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Triomar™ (omega-3 fatty acids) | Haukeland University Hospital | The Multiple Sclerosis National Competence Centre;The Norwegian Multiple sclerosis Society;Pronova BioPharma;Serono Nordic;Amersham Health | Completed | 18 Years | 55 Years | Both | 100 | Phase 2/Phase 3 | Norway |
| 767 | NCT00203099 (ClinicalTrials.gov) | December 2004 | 13/9/2005 | Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine | A Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS) | Relapse Remitting Multiple Sclerosis | Drug: Glatiramer Acetate, N-Acetylcysteine | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 18 | Phase 2 | Canada |
| 768 | EUCTR2004-000145-38-CZ (EUCTR) | 16/11/2004 | 24/09/2004 | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis. | Relapse-remitting Multiple Sclerosis (RRMS) Classification code 10048393 | Product Name: Human monoclonal antibody (CNTO 1275) to interleukin-12p40 Product Code: CNTO 1275 Other descriptive name: Anti-IL-12; Human anti-IL-12 Mab; Human anti-IL-12 IgG1 Mab | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Hungary;Czech Republic;United Kingdom | ||
| 769 | NCT00168701 (ClinicalTrials.gov) | October 2004 | 9/9/2005 | Efficacy and Safety of BG00012 in MS | Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: BG00012 | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 260 | Phase 2 | Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Sweden;Switzerland;Turkey;United Kingdom |
| 770 | EUCTR2004-000073-64-FI (EUCTR) | 03/09/2004 | 14/07/2004 | A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - - | A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Effects of L-000124467 on Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis as Measured by MRI. Satunnaistettu, kaksoissokkoutettu ja lumekontrolloitu rinnakkaisryhmin etenevä tutkimus, jossa tutkitaan L-000124467 -lääkkeen kliinistä tehoa, turvallissuutta ja siedettävyyttä aaltomaista MS-tautia sairastavilla potilailla MRI menetelmällä. - - | Aaltomainen MS-tauti | Product Code: L-000124467 | Merck & Co., Inc./Suomen MSD Oy | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Finland | ||
| 771 | NCT00097331 (ClinicalTrials.gov) | September 2004 | 22/11/2004 | Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis | A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Three Months Administration of SB-683699 (150 - 1200mg Twice Daily) in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: SB683699 | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 261 | Phase 2 | Belgium;Germany;Poland;Russian Federation;Spain;United States;Canada;France;Italy;Romania |
| 772 | EUCTR2004-000762-13-IT (EUCTR) | 31/08/2004 | 31/08/2012 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit. MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Glatiramer acetate Product Code: TV-5010 INN or Proposed INN: Glatiramer acetate | TEVA ITALIA srl | NULL | Not Recruiting | Female: yes Male: yes | 7 | Phase 2 | Italy | ||
| 773 | NCT00239655 (ClinicalTrials.gov) | August 2004 | 13/10/2005 | A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)(0812-003)(COMPLETED) | A Randomized, Double-Blind Placebo Controlled, Parallel Groups Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by MRI | Relapsing-Remitting Multiple Sclerosis | Drug: MK0812 | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 55 Years | Both | 120 | Phase 2 | Canada;Finland;Germany;United Kingdom;United States |
| 774 | NCT00207727 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis | A Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: CNTO 1275 | Centocor, Inc. | Centocor BV | Completed | 18 Years | 65 Years | All | 249 | Phase 2 | Australia;Canada;Czech Republic;Hungary;Poland;United Kingdom;United States |
| 775 | NCT00223301 (ClinicalTrials.gov) | July 2004 | 19/9/2005 | Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis | A One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple Sclerosis | Multiple Sclerosis | Drug: Mycophenolate Mofetil (cellcept) | University of Texas Southwestern Medical Center | Roche Pharma AG;Biogen Idec | Completed | 21 Years | 45 Years | Both | 24 | Phase 2/Phase 3 | United States |
| 776 | NCT00087529 (ClinicalTrials.gov) | June 2004 | 9/7/2004 | A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis | A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: placebo;Drug: rituximab | Genentech, Inc. | NULL | Completed | 18 Years | 65 Years | All | 439 | Phase 2/Phase 3 | Canada;United States |
| 777 | NCT00203112 (ClinicalTrials.gov) | June 2004 | 13/9/2005 | Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline | A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA). | Relapse Remitting Multiple Sclerosis | Drug: glatiramer acetate with minocycline;Drug: Glatiramer acetate with placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 44 | Phase 2 | Canada |
| 778 | NCT00217295 (ClinicalTrials.gov) | April 2004 | 14/9/2005 | A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis | A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis. | Multiple Sclerosis | Drug: Avonex and Topamax | Multiple Sclerosis Institute | NULL | Recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | United States |
| 779 | NCT00300716 (ClinicalTrials.gov) | April 2004 | 8/3/2006 | Trial of Memantine for Cognitive Impairment in Multiple Sclerosis | Double Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple Sclerosis | Multiple Sclerosis;Cognition Disorders | Drug: Memantine | Oregon Health and Science University | Forest Laboratories;University of Southern California;University of Texas Southwestern Medical Center;MS-Hub Seattle | Completed | 18 Years | 65 Years | All | 82 | Phase 2/Phase 3 | United States |
| 780 | NCT00086671 (ClinicalTrials.gov) | April 2004 | 7/7/2004 | Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS) | A 24-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Finding, Safety, Tolerability, and Efficacy Study of the Human Anti-IL-12 Antibody ABT-874 in Subjects With Multiple Sclerosis With a 24-Week Double-Blind, Active Extension Phase | Multiple Sclerosis | Drug: ABT-874/Human monoclonal antibody against IL-12;Drug: Placebo | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 60 Years | Both | 215 | Phase 2 | United States;Canada;Germany;Netherlands;United Kingdom |
| 781 | NCT00228397 (ClinicalTrials.gov) | November 2003 | 16/9/2005 | Study Evaluating CCI-779 in Relapsing Multiple Sclerosis | A Multicenter, Randomized, Double-blind, Long-term Extension Study to Determine the Safety, Tolerability, and Preliminary Efficacy of CCI-779 in Subjects With Relapsing Multiple Sclerosis. | Multiple Sclerosis, Relapsing-Remitting | Drug: CCI-779 | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | N/A | N/A | Both | 221 | Phase 2 | NULL |
| 782 | NCT00071838 (ClinicalTrials.gov) | October 30, 2003 | 31/10/2003 | Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis | Zenapax (Daclizumab) Admin to Pts With Multiple Sclerosis (ZAP MS): Effect of Intravenously Admin Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (Daclizumab) on Inflammatory Activity in the Central Nervous System | Multiple Sclerosis, Relapsing-Remitting | Drug: Daclizumab | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 18 Years | 65 Years | All | 16 | Phase 2 | United States |
| 783 | NCT00616187 (ClinicalTrials.gov) | October 2003 | 5/2/2008 | Atorvastatin in Relapsing-Remitting Multiple Sclerosis | Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: interferon beta treatment to add-on atorvastatin treatment;Drug: untreated to atorvastatin treatment | Charite University, Berlin, Germany | German Research Foundation;German Federal Ministry of Education and Research;Pfizer | Completed | 18 Years | 55 Years | All | 41 | Phase 2 | NULL |
| 784 | NCT00296205 (ClinicalTrials.gov) | October 2003 | 23/2/2006 | Phase II High-Dose Cyclophosphamide for Multiple Sclerosis | Phase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide | Stony Brook University | NULL | Withdrawn | 18 Years | 75 Years | Both | 25 | Phase 2 | United States |
| 785 | NCT00202982 (ClinicalTrials.gov) | August 2003 | 12/9/2005 | A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose | A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients | Relapse-Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mg | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 90 | Phase 2 | United States |
| 786 | NCT00079495 (ClinicalTrials.gov) | July 2003 | 8/3/2004 | Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: NBI-5788 | Neurocrine Biosciences | Immune Tolerance Network (ITN) | Completed | 18 Years | 55 Years | Both | 150 | Phase 2 | NULL |
| 787 | NCT00235989 (ClinicalTrials.gov) | June 2003 | 10/10/2005 | Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis | An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta 1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | All | 63 | Phase 2 | United States |
| 788 | NCT00097760 (ClinicalTrials.gov) | June 2003 | 30/11/2004 | Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis | Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA) | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab;Drug: Placebo | Biogen Idec | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 110 | Phase 2 | NULL |
| 789 | NCT00203073 (ClinicalTrials.gov) | June 2003 | 13/9/2005 | A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis. | A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantrone | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | Both | 40 | Phase 2 | United States;Canada |
| 790 | NCT00333138 (ClinicalTrials.gov) | May 2003 | 1/6/2006 | Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis | Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase | Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 60 Years | All | 281 | Phase 2 | Canada;Denmark;Finland;France;Germany;Italy;Poland;Portugal;Spain;Switzerland;United Kingdom |
| 791 | NCT00053417 (ClinicalTrials.gov) | February 2003 | 29/1/2003 | Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis | Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP) | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 206 | Phase 2 | United States;Canada |
| 792 | NCT00298662 (ClinicalTrials.gov) | February 2003 | 2/3/2006 | Combination Therapy of Betaseron-Prograf in Multiple Sclerosis | A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents | Multiple Sclerosis | Drug: Interferon beta-1b and Tacrolimus | Clinique de sclérose en plaques et neuromusculaire de l'Outaouais | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | Canada |
| 793 | NCT00912860 (ClinicalTrials.gov) | January 2003 | 2/6/2009 | Immunogenicity and Safety Study of Serum-Free Avonex | A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1a | Biogen Idec | NULL | Completed | 18 Years | 60 Years | Both | 155 | Phase 2 | NULL |
| 794 | NCT00220779 (ClinicalTrials.gov) | December 2002 | 13/9/2005 | Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis | Randomized, Double-Blind, Placebo-Controlled Study to Compare the Effects of Different Dose Regimens of IGIV Chromatography (IGIV-C), 10% Treatment on Relapses in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | 55 Years | All | 128 | Phase 2 | United States;Austria;Canada;Czech Republic;Germany;Greece;Hungary;Israel;Poland;Slovakia;Sweden;United Kingdom |
| 795 | NCT00050778 (ClinicalTrials.gov) | December 2002 | 19/12/2002 | A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: Interferon beta-1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg | Genzyme, a Sanofi Company | Bayer | Completed | 18 Years | 50 Years | All | 334 | Phase 2 | United States;Croatia;Poland;Russian Federation;United Kingdom |
| 796 | NCT00893217 (ClinicalTrials.gov) | November 2002 | 4/5/2009 | BEYOND Pilot Study | Double-blind, Randomized, Parallel Group, Multicenter Study of the Safety and Tolerability of Betaseron 500 Mcg Subcutaneously Every Other Day and Betaseron 250 Mcg Subcutaneously Every Other Day for at Least 12 Weeks in Patients With RRMS | Multiple Sclerosis;Relapsing-Remitting | Drug: Betaseron (Interferon beta-1b, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | Both | 71 | Phase 2 | United States |
| 797 | NCT00151801 (ClinicalTrials.gov) | May 2002 | 8/9/2005 | Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients | Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: estroprogestins;Drug: interferon-beta 1a | S. Andrea Hospital | NULL | Recruiting | 18 Years | 40 Years | Female | 200 | Phase 2 | Italy |
| 798 | NCT00067327 (ClinicalTrials.gov) | February 2002 | 15/8/2003 | Treatment of Multiple Sclerosis Using Over the Counter Inosine | Treatment of Multiple Sclerosis Using Over the Counter Inosine | Multiple Sclerosis, Relapsing-Remitting | Drug: Inosine | National Center for Complementary and Integrative Health (NCCIH) | NULL | Completed | 18 Years | 60 Years | Both | 30 | Phase 2 | United States |
| 799 | NCT00228163 (ClinicalTrials.gov) | January 2002 | 26/9/2005 | Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: teriflunomide (HMR1726) | Sanofi | NULL | Completed | 18 Years | 65 Years | Both | 147 | Phase 2 | Canada;France |
| 800 | NCT00035529 (ClinicalTrials.gov) | November 2001 | 3/5/2002 | A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis | A Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: BMS 188667 (Abatacept) | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 55 Years | Both | Phase 2 | United States | |
| 801 | NCT00202410 (ClinicalTrials.gov) | November 2001 | 12/9/2005 | Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis | Phase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, Randomized, Single Blind Study. | Multiple Sclerosis | Biological: Bacille of Calmette-Guerin;Other: placebo | S. Andrea Hospital | Multiple Sclerosis Italian Foundation (FISM);Istituto Superiore di Sanità | Completed | 18 Years | N/A | Both | 80 | Phase 2/Phase 3 | Italy |
| 802 | NCT00043264 (ClinicalTrials.gov) | June 2001 | 7/8/2002 | Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis | Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis | Multiple Sclerosis | Drug: Rifampin;Drug: Azithromycin | National Center for Research Resources (NCRR) | National Multiple Sclerosis Society | Completed | 18 Years | 65 Years | Both | 40 | Phase 2 | United States |
| 803 | NCT01487096 (ClinicalTrials.gov) | April 2001 | 5/12/2011 | Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (placebo for teriflunomide) | Sanofi | NULL | Completed | 18 Years | 65 Years | Both | 179 | Phase 2 | Canada;France |
| 804 | NCT00011375 (ClinicalTrials.gov) | February 2001 | 16/2/2001 | Rolipram to Treat Multiple Sclerosis | Safety, Tolerability & Effects of Rolipram on Inflammatory Activity in the Central Nervous System in Multiple Sclerosis. A Phase II, Open Label Crossover Trial Using MRI as an Outcome Measure | Multiple Sclerosis | Drug: Rolipram | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 52 | Phase 2 | United States |
| 805 | NCT00001934 (ClinicalTrials.gov) | September 1999 | 3/11/1999 | Zenapax to Treat Multiple Sclerosis | Effect of the Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (IL-2R-Alpha; Zenapax(Registered Trademark)) on Inflammatory Activity in the CNS in MS in a Baseline-to-Treatment, Cross-Over, MRI-Controlled Single Center Phase I/II Trial | Multiple Sclerosis | Drug: Zenapax | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 18 Years | 65 Years | Both | 22 | Phase 2 | United States |
| 806 | NCT00219908 (ClinicalTrials.gov) | July 1999 | 16/9/2005 | Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis | Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b | Relapsing-Remitting Multiple Sclerosis | Drug: Mitoxantrone | Rennes University Hospital | Bayer;Wyeth is now a wholly owned subsidiary of Pfizer;Farmades, Italy | Terminated | 18 Years | 45 Years | Both | 124 | Phase 2 | France;Italy |
| 807 | NCT00040482 (ClinicalTrials.gov) | April 1999 | 26/6/2002 | High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis | Intensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapy | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Completed | 18 Years | 60 Years | All | 10 | Phase 2 | United States |
| 808 | NCT00001781 (ClinicalTrials.gov) | February 1998 | 3/11/1999 | Safety, Tolerability, and Effectiveness of CGP77116 in Patients With Multiple Sclerosis (MS) | Open-Label Baseline vs. Treatment Trial Evaluating the Safety, Tolerability and Effect on MRI Lesion and Immunology Parameters of CGP 77116 in Patients With Multiple Sclerosis Mark | Multiple Sclerosis | Drug: CGP 77116 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 25 | Phase 2 | United States |
| 809 | NCT00001669 (ClinicalTrials.gov) | July 1997 | 3/11/1999 | A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients | A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients | Multiple Sclerosis | Drug: rhIGF-1 (CEP-151) | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 15 | Phase 2 | United States |
| 810 | EUCTR2015-000137-78-AT (EUCTR) | 17/09/2015 | Mesenchymal stem cells therapy for patients with multiple sclerosis | Randomised, double-blind, cross-over phase II study with intravenous autologous mesenchymal stem cells vs. placebo for multiple sclerosis patients in Austria (MESEMS Austria) | multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Human autologous mesenchymal stem cells INN or Proposed INN: MSC2015 Other descriptive name: UNDIFFERENTIATED AUTOLOGOUS MESENCHYMAL STEM CELLS | SALK - Gemeinnützige Salzburger Landeskliniken Betriebsges. m.b.H., Christian-Doppler-Klinik, UK für Neurologie der PMU | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Austria | ||||
| 811 | EUCTR2008-008719-25-DE (EUCTR) | 16/02/2009 | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Code: BAF312 Product Name: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Finland;Germany;Spain;Italy | |||
| 812 | EUCTR2006-006465-16-DE (EUCTR) | 03/05/2007 | Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MS | Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MS | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: human recombinant growth hormone | University of Leipzig | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | ||||
| 813 | EUCTR2014-000728-97-NL (EUCTR) | 08/05/2014 | Regulation of the stress-axis by vitamin D in subjects with multiple sclerosis. | Regulation of the stress-axis by vitamin D3 in subjects with multiple sclerosis; a double-blinded, randomized, placebo-controlled study - Vitamin D3 and the stress-axis in MS | Relapsing remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vigantol® Oil Product Name: Vigantol® Oil Product Code: EMD 28162 | Academic MS Center Limburg | NULL | Not Recruiting | Female: yes Male: no | Phase 2 | Netherlands | ||||
| 814 | EUCTR2009-014724-32-DE (EUCTR) | 26/10/2010 | Boswellic Acids in Multiple Sclerosis | SAFETY, TOLERABILITY AND MECHANISM OF ACTION OF BOSWELLIC ACIDS (BA) IN MULTIPLE SCLEROSIS (MS) AND CLINICALLY ISOLATED SYNDROME (CIS): A MRI-CONTROLLED, MULTICENTER, BASELINE-TO-TREATMENT, 32-WEEKS, OPEN-LABEL, PHASE IIA TRIAL IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS OR CLINICALLY ISOLATED SYNDROME - SABA | Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BOSWELAN Product Code: BOSWELAN INN or Proposed INN: BOSWELAN Other descriptive name: Boswellia serrata extract PS0201Bo capsules | University Medical Center Eppendorf | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany | |||
| 815 | EUCTR2008-005213-22-DE (EUCTR) | 22/08/2008 | SUPREMES - Sunphenon in progressive forms of multiple sclerosis | SUPREMES - Sunphenon in progressive forms of multiple sclerosis - SUPREMES | primary and secondary progressive forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Sunphenon Other descriptive name: Sunphenon EGCg | Charite Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Germany | |||
| 816 | EUCTR2018-003008-38-FR (EUCTR) | 29/03/2019 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Plegridy Product Name: PEGylated Interferon Beta-1a Product Code: BIIB017 INN or Proposed INN: PEGINTERFERON BETA-1A Other descriptive name: PEGINTERFERON BETA-1A Trade Name: AVONEX® Product Name: interferon beta-1a Product Code: IFN ß-1a INN or Proposed INN: Interferon Beta-1a Other descriptive name: Interferon Beta-1a | Biogen Idec Research Limited | NULL | NA | Female: yes Male: yes | 142 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany | |||
| 817 | EUCTR2004-003799-13-IE (EUCTR) | 13/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | |||
| 818 | EUCTR2021-006075-42-DE (EUCTR) | 17/06/2022 | Clinical study testing the efficacy and safety of Ravulizumab in pediatric patients with NMOSD | A Phase 2/3, Open-label, Historical-controlled, Single-arm, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of Ravulizumab in Children and Adolescents With Aquaporin-4 antibody Positive (AQP4-Ab [+]) Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 2/3 Efficacy and Safety Study of Ravulizumab in Pediatric Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: ULTOMIRIS® Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 12 | Phase 2;Phase 3 | France;United States;Canada;Spain;Germany;Italy;Japan;Korea, Republic of | |||
| 819 | EUCTR2021-003528-33-PL (EUCTR) | 22/03/2022 | Neuromyelitis Optica Spectrum Disorder Inebilizumab Study in Children and Adolescents | An Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects with Neuromyelitis Optica Spectrum Disorder | Neuromyelitis optica spectrum disorder (NMOSD; also known as Devic's syndrome and previously known as neuromyelitis optica [NMO]) MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Inebilizumab Product Code: VIB0551 INN or Proposed INN: Inebilizumab | Horizon Therapeutics Ireland DAC | NULL | NA | Female: yes Male: yes | 15 | Phase 2 | France;United States;Serbia;Canada;Argentina;Spain;Brazil;Poland;Netherlands;United Kingdom;Sweden |