13. Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
Clinical trials : 3,342 / Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
| 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 | NCT05147532 (ClinicalTrials.gov) | January 2022 | 15/10/2021 | Remyelination in Multiple Sclerosis: a PET-MR Longitudinal Study Investigating Individual Profiles of Myelin Repair and the Contribution of Neuroinflammation | Remyelination in Multiple Sclerosis: a PET-MR Longitudinal Study Investigating Individual Profiles of Myelin Repair and the Contribution of Neuroinflammation | Multiple Sclerosis;Inflammatory Disease | Procedure: PET-MRI with [18F]-Florbetaben and PET-MRI with [18F]-DPA-714 | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 18 Years | 55 Years | All | 80 | N/A | NULL |
| 2 | 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 | Recruiting | 18 Years | 55 Years | All | 120 | Phase 2 | United States;Bulgaria;Canada;Czechia;France;Germany;Spain;Turkey;Ukraine |
| 3 | 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 |
| 4 | ChiCTR2000034098 | 2020-07-01 | 2020-06-23 | A New Quantitative Method Used to Evaluate Cervical Spinal Cord Damage in Multiple Sclerosis: Diffusional Kurtosis Imaging Research | A New Quantitative Method Used to Evaluate Cervical Spinal Cord Damage in Multiple Sclerosis: Diffusional Kurtosis Imaging Research | Multiple Sclerosis | Gold Standard:Conventional cervical MRI;Index test:Diffusional Kurtosis Imaging; | The First Hospital of Jilin University | NULL | Pending | Both | Target condition:48;Difficult condition:0 | China | |||
| 5 | NCT04458688 (ClinicalTrials.gov) | July 2020 | 30/6/2020 | Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis | Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study | Multiple Sclerosis, Relapsing-Remitting | Other: Observation of Ocrelizumab as Treatment in RRMS Patients | Wayne State University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 80 | NULL | |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | Poland;Ukraine;Romania;Bulgaria | ||
| 10 | NCT03691077 (ClinicalTrials.gov) | November 11, 2018 | 28/9/2018 | Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714 | A Prospective Study Evaluating the Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in Multiple Sclerosis Using PET-MRI With 18F-DPA714 | Multiple Sclerosis;Relapse;Primary Progressive Multiple Sclerosis | Drug: Ocrelizumab | Assistance Publique - Hôpitaux de Paris | Roche Pharma AG;Institut du Cerveau et de la Moelle épinière | Recruiting | 18 Years | 60 Years | All | 51 | Phase 3 | France |
| 11 | NCT03396822 (ClinicalTrials.gov) | September 24, 2018 | 4/1/2018 | Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis | Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis | Multiple Sclerosis | Drug: Gadoteridol | University of Maryland, Baltimore | Genentech, Inc. | Active, not recruiting | 18 Years | 65 Years | All | 24 | United States | |
| 12 | 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 | ||
| 13 | NCT03610139 (ClinicalTrials.gov) | May 21, 2018 | 13/7/2018 | Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients | Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical Trial | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting;Clinically Isolated Syndrome;Clinically Isolated Syndrome, CNS Demyelinating;Vitamin D3 Deficiency | Dietary Supplement: Vitamin D3 | American University of Beirut Medical Center | NULL | Recruiting | 18 Years | N/A | All | 162 | N/A | Lebanon |
| 14 | ChiCTR-DND-17013749 | 2017-12-01 | 2017-12-07 | Application of 3.0 T MRI 3D sequences of CUBE-T2 FLAIR?DIR for brain lesions of childhood-onset multiple sclerosis | Application of 3.0 T MRI 3D sequences of CUBE-T2 FLAIR?DIR for brain lesions of childhood-onset multiple sclerosis | childhood-onset multiple sclerosis | Gold Standard:CUBE-T2 FLAIR scanning;Index test:DIR scanning; | Children's Hospital of Chongqing Medical University | NULL | Recruiting | Both | Target condition:80;Difficult condition:0 | China | |||
| 15 | NCT03021317 (ClinicalTrials.gov) | February 2017 | 12/1/2017 | Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses | Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses | Multiple Sclerosis | Drug: ACTHar | University of Chicago | NULL | Not yet recruiting | 18 Years | N/A | All | 18 | Phase 4 | NULL |
| 16 | NCT03193086 (ClinicalTrials.gov) | January 1, 2017 | 14/6/2017 | The Effect of Alemtuzumab on the Blood-brain-barrier and the Brain's Metabolism in Multiple Sclerosis Patients | The Effect of Alemtuzumab on the Blood-brain-barrier and Cerebral Metabolism in Multiple Sclerosis Patients; a New MRI Method for Treatment Response Evaluation in Multiple Sclerosis | Multiple Sclerosis | Drug: Alemtuzumab | Glostrup University Hospital, Copenhagen | Genzyme, a Sanofi Company | Recruiting | 18 Years | 60 Years | All | 35 | N/A | Denmark |
| 17 | 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 | ||
| 18 | NCT02644083 (ClinicalTrials.gov) | February 2016 | 23/12/2015 | Tecfidera and MRI for Brain Energy in MS | Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate | Multiple Sclerosis | Drug: Dimethyl fumarate | Oregon Health and Science University | Biogen | Terminated | 18 Years | 55 Years | All | 4 | United States | |
| 19 | NCT02677077 (ClinicalTrials.gov) | December 31, 2015 | 3/12/2015 | Clinical Disease Activity With Long Term Natalizumab Treatment | MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab | Relapsing-Remitting Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 277 | Belgium;Czechia;Czech Republic | |
| 20 | 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 | ||
| 21 | 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 |
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | EUCTR2014-003209-14-FR (EUCTR) | 01/09/2014 | 18/06/2015 | ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS | ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFF | MULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI 300 mg solution à diluer pour perfusion INN or Proposed INN: NATALIZUMAB | Hôpitaux Universitaires de Strasbourg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | NCT01973517 (ClinicalTrials.gov) | April 2014 | 16/10/2013 | High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases | 7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases | Multiple Sclerosis | Drug: Feraheme;Drug: Gadolinium-based contrast | Stanford University | NULL | Withdrawn | 18 Years | N/A | All | 0 | United States | |
| 31 | EUCTR2013-004616-21-DE (EUCTR) | 13/03/2014 | 04/02/2014 | A study to assess immune function and typical disease characteristics in patients with multiple sclerosis, when switching from the medication Natalizumab to the medication Gilenya. | A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod) - ToFingo Successor | 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: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB | Universitätsklinikum Münster | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 32 | NCT02325440 (ClinicalTrials.gov) | March 2014 | 4/9/2014 | Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya | A 32-week, Monocentric, Exploratory, Single Arm Study to Assess Immune Function and MRI Disease Activity in Patients With RRMS Transferred From Previous Treatment With Natalizumab to Gilenya® (Fingolimod) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Natalizumab | University Hospital Muenster | Novartis | Recruiting | 18 Years | 65 Years | Both | 15 | Phase 4 | Germany |
| 33 | 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 |
| 34 | NCT01906684 (ClinicalTrials.gov) | August 2013 | 19/7/2013 | Comprehensive Analysis of Relapse in Multiple Sclerosis | Comprehensive Analysis of Relapse in Multiple Sclerosis | Multiple Sclerosis | Drug: Acthar Gel | Tanner Foundation for Multiple Sclerosis | Questcor Pharmaceuticals, Inc.;Auburn University MRI Research Center;iReportoire Inc | Not yet recruiting | 19 Years | 65 Years | Both | 20 | N/A | United States |
| 35 | 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 |
| 36 | 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 | ||
| 37 | EUCTR2012-000287-17-IT (EUCTR) | 21/05/2012 | 18/06/2012 | functional MRI study to evaluate improvement of hand performance after combined motor exercise and aminopiridine assumption | PROMOTION OF FUNCTIONAL RESTORATION THROUGH PHARMACOLOGICAL MODULATION OF BRAIN PLASTICITY WITH AMINOPYRIDINE IN PATIENTS WITH MULTIPLE SCLEROSIS STUDIED BY FUNCTIONAL MRI | Patients with MS, without relevant medical conditions, with right upper limb impairment assessed by a hand dexterity test will be included.Patients will be in a non-active phase of the disease and under a stable pharmacological treatment.They will not be included if they have received physiotherapy in the previous few months. Healthy volunteers will be recruited if they have no relevant medical condition and no contraindication to perform a MRI scan. MedDRA version: 14.1;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FAMPYRA INN or Proposed INN: FAMPRIDINE | FONDAZIONE SANTA LUCIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 38 | EUCTR2011-002333-19-IT (EUCTR) | 19/03/2012 | 14/03/2012 | Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis. | 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: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Arzerra INN or Proposed INN: OFATUMUMAB Other descriptive name: NA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy | |||
| 39 | EUCTR2011-002333-19-CZ (EUCTR) | 27/02/2012 | 31/10/2011 | 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: 14.1;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 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Norway;Italy | |||
| 40 | NCT02967380 (ClinicalTrials.gov) | December 14, 2011 | 13/9/2015 | Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases | Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions | Adult Anaplastic (Malignant) Meningioma;Adult Anaplastic Astrocytoma;Adult Anaplastic Ependymoma;Adult Anaplastic Oligodendroglioma;Adult Brain Stem Glioma;Adult Choroid Plexus Neoplasm;Adult Diffuse Astrocytoma;Adult Ependymoblastoma;Adult Ependymoma;Adult Giant Cell Glioblastoma;Adult Glioblastoma;Adult Gliosarcoma;Adult Grade II Meningioma;Adult Medulloblastoma;Adult Mixed Glioma;Adult Oligodendroglioma;Adult Papillary Meningioma;Adult Pineal Gland Astrocytoma;Adult Pineoblastoma;Adult Primary Melanocytic Lesion of Meninges;Adult Supratentorial Primitive Neuroectodermal Tumor;Malignant Adult Intracranial Hemangiopericytoma;Metastatic Malignant Neoplasm in the Brain;Multiple Sclerosis;Recurrent Adult Brain Neoplasm | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging;Drug: Gadobenate Dimeglumine;Drug: Gadobutrol;Radiation: Gadopentetate Dimeglumine | University of Southern California | National Cancer Institute (NCI) | Terminated | 18 Years | N/A | All | 14 | N/A | United States |
| 41 | EUCTR2011-002333-19-DE (EUCTR) | 29/11/2011 | 09/09/2011 | 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: 15.0;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] | Product Name: Ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Norway;Germany;Italy | |||
| 42 | 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 | ||
| 43 | EUCTR2011-002333-19-NL (EUCTR) | 23/11/2011 | 05/10/2011 | 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: 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 Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 196 | United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Germany;Norway;Netherlands;Italy | |||
| 44 | 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 |
| 45 | 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 | ||
| 46 | 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 |
| 47 | NCT01395316 (ClinicalTrials.gov) | June 2011 | 13/7/2011 | Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis | Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Alemtuzumab | University of Chicago | Genzyme, a Sanofi Company | Completed | 18 Years | 50 Years | All | 8 | Phase 4 | NULL |
| 48 | EUCTR2010-023678-38-IT (EUCTR) | 20/04/2011 | 02/02/2011 | High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND | High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND | patients with multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10028245 | Trade Name: MANTADAN*20CPR 100MG INN or Proposed INN: Amantadine Trade Name: AMPYRA INN or Proposed INN: Ampyra | FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 49 | EUCTR2011-000150-31-IT (EUCTR) | 13/04/2011 | 28/12/2011 | EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY. | EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY. | Multiple Sclerosis patients MedDRA version: 14.1;Level: HLGT;Classification code 10012303;Term: Demyelinating disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate | FONDAZIONE DON CARLO GNOCCHI ONLUS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 50 | NCT01307332 (ClinicalTrials.gov) | March 2011 | 26/1/2011 | Advanced MRI Measures of Repair in Alemtuzumab Treated Patients | Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients | Relapsing Remitting Multiple Sclerosis | Drug: MabCampath-1h | University of British Columbia | Genzyme, a Sanofi Company | Completed | 18 Years | 50 Years | All | 27 | Phase 3 | Canada |
| 51 | NCT01085318 (ClinicalTrials.gov) | June 30, 2010 | 10/3/2010 | Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial | A Twenty-four Week, Two Arm, Pilot Trial to Evaluate Remyelination/ Demyelination, Gray Matter Volume and Iron Deposition in the Central Nervous System (CNS) and Immune Status of Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) Treated With Rebif® 44 mcg Subcutaneously (sc) Three Times a Week (Tiw) Compared to a Healthy Control Group | Multiple Sclerosis | Drug: Rebif | EMD Serono | NULL | Completed | 18 Years | 65 Years | All | 38 | Phase 4 | United States |
| 52 | EUCTR2009-014857-34-DE (EUCTR) | 01/02/2010 | 21/12/2009 | Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MS | Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MS | Patients with clinically definite MS or a clinically isolated episode of CNS involvement and disease dissemination in space, according to the McDonald’s criteria MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Gadovist 1.0 mmol/ml Injektionslösung Product Code: V08CA09 INN or Proposed INN: GADOBUTROL Other descriptive name: GADOBUTROL Trade Name: Dotarem 0,5mmol/ml, Product Code: V08CA02 INN or Proposed INN: gadoteric acid | Universitätsklinikum Erlangen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Germany | |||
| 53 | NCT01414634 (ClinicalTrials.gov) | February 2010 | 8/8/2011 | Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells | Establish Tolerance in Multiple Sclerosis With Peptide-coupled, Peripheral Blood Mononuclear Cells - A MRI-controlled, Single Center, Phase I Trial in Relapsing-remitting MS Patients | Multiple Sclerosis, Relapsing-Remitting | Biological: ETIMS | Universitätsklinikum Hamburg-Eppendorf | NULL | Completed | 18 Years | 55 Years | All | 9 | Phase 1/Phase 2 | NULL |
| 54 | EUCTR2009-016140-39-ES (EUCTR) | 19/01/2010 | 28/10/2009 | MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. | MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. | Realce de contraste en resonancia magnética enpacientes con Síndrome Clínico Aislado orecaída de Esclerosis Múltiple con resonanciamagnética anormal anterior después de laadministración de dosis única y acumulada deGADOVIST®High field strength MRI in patients with clinically isolated syndromes or relapsing MS with abnormal previous MRI after single and double dose of Gadovist® | Trade Name: GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado INN or Proposed INN: GADOBUTROL Other descriptive name: GADOBUTROL | Institut Diagnostic per la Imatge | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 55 | 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 |
| 56 | EUCTR2008-004408-29-DE (EUCTR) | 27/11/2009 | 31/07/2008 | ESTABLISH TOLERANCE IN MS WITH PEPTIDE-PULSED, PERIPHERAL BLOOD MONONUCLEAR CELLS - A MRI-CONTROLLED, SINGLE CENTER, BASELINE-TO-TREATMENT CROSS-OVER, PHASE I/IIA TRIAL IN RELAPSING-REMITTING MS PATIENTS - ETIMS - - ETIMS | ESTABLISH TOLERANCE IN MS WITH PEPTIDE-PULSED, PERIPHERAL BLOOD MONONUCLEAR CELLS - A MRI-CONTROLLED, SINGLE CENTER, BASELINE-TO-TREATMENT CROSS-OVER, PHASE I/IIA TRIAL IN RELAPSING-REMITTING MS PATIENTS - ETIMS - - ETIMS | relapsing-remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ETIMS (EDC-fixed autologous PBMCs coupled with 7 immunodominant myelin peptides in MS patients) Product Code: ETIMS | University Medical Center Hamburg-Eppendorf | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Germany | |||
| 57 | 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 | ||
| 58 | EUCTR2009-011626-34-CZ (EUCTR) | 21/09/2009 | 27/07/2009 | 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: 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: 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 | Russian Federation;Czech Republic;Ukraine;Serbia;Sweden | |||
| 59 | 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 | ||
| 60 | 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 | ||
| 61 | 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 | ||
| 62 | NCT01567553 (ClinicalTrials.gov) | April 2009 | 24/2/2012 | The Inflammatory Process and the Medical Imaging in Patients With an Inflammatory Disease of the Central Nervous System. | Early Neuroinflammatory Changes as a Prognostic Marker in Clinically Isolated Syndromes Patients. | Multiple Sclerosis (MS);Inflammatory Disease | Other: USPIO MRI - Gadolinium MRI | Rennes University Hospital | Bayer;Bayer | Terminated | 18 Years | 45 Years | Both | 37 | N/A | France |
| 63 | 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 |
| 64 | 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 | ||
| 65 | 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 | ||
| 66 | 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 | ||
| 67 | 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 | ||
| 68 | 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 | ||
| 69 | NCT00676715 (ClinicalTrials.gov) | July 31, 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 |
| 70 | 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 | ||
| 71 | 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 | ||
| 72 | 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 | ||
| 73 | 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 | ||
| 74 | 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 | ||
| 75 | 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 | ||
| 76 | 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 | ||
| 77 | 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 | ||
| 78 | 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 | 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 | ||
| 79 | 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 | ||
| 80 | 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 | ||
| 81 | 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 | ||
| 82 | 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 | ||
| 83 | 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 |
| 84 | 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 | ||
| 85 | 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 | ||
| 86 | 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 | ||
| 87 | EUCTR2008-007162-32-IT (EUCTR) | 30/10/2007 | 06/11/2008 | ADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSM | ADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSM | Multiple Sclerosis MedDRA version: 9.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders | Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a | ISTITUTO C. MONDINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 88 | 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 | ||
| 89 | 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 |
| 90 | EUCTR2006-001337-17-DE (EUCTR) | 25/09/2007 | 26/03/2007 | Characterisation of multiple sclerosis pathology by ultra small particles of iron oxide (USPIO)” in comparison with conventional and advanced MRI imaging techniques[Charakterisierung der Multiple Sklerose Pathologie durch ultra small particles of iron oxide (USPIO)” im Vergleich zu konventionellen und fortgeschrittenen MRT Techniken] - MS_USPIO_MPIP | Characterisation of multiple sclerosis pathology by ultra small particles of iron oxide (USPIO)” in comparison with conventional and advanced MRI imaging techniques[Charakterisierung der Multiple Sklerose Pathologie durch ultra small particles of iron oxide (USPIO)” im Vergleich zu konventionellen und fortgeschrittenen MRT Techniken] - MS_USPIO_MPIP | Patients with Multiple Sclerosis (MS, N=90) and patients with a clinically isolated syndrome (ref. to as CIS in literature, i. e. not a clinically definite MS but a syndrome that may occur as first sign of MS early in the course, N=15) are planned to be investigated in the proposed clinical trial. MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: ultra small particles of iron oxide (USPIO) Product Code: SH U 555 C INN or Proposed INN: SH U 555 C Other descriptive name: Ultrasmall particles of iron oxide | Max-Planck-Institute of Psychiatry | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 91 | EUCTR2006-003037-32-LT (EUCTR) | 11/09/2007 | 27/11/2006 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 92 | EUCTR2006-002633-20-LT (EUCTR) | 07/09/2007 | 05/07/2007 | 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 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 93 | NCT00937157 (ClinicalTrials.gov) | September 2007 | 9/7/2009 | Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA) | Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study | Multiple Sclerosis | Drug: Copaxone | University at Buffalo | Teva Neuroscience, Inc. | Completed | 18 Years | 65 Years | All | 12 | N/A | United States |
| 94 | 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 | ||
| 95 | 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 | ||
| 96 | 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 | ||
| 97 | 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 | ||
| 98 | 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 | ||
| 99 | 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 | ||
| 100 | EUCTR2008-000955-90-IT (EUCTR) | 24/04/2007 | 12/03/2008 | Randomized, single-blind, clinical and MRI study for evaluation of safety and efficacy of N-Acetyl Cysteine (NAC) associated with high-dose beta-Interferon in Relapsing-Remitting (RR) multiple sclerosis patients - renac | Randomized, single-blind, clinical and MRI study for evaluation of safety and efficacy of N-Acetyl Cysteine (NAC) associated with high-dose beta-Interferon in Relapsing-Remitting (RR) multiple sclerosis patients - renac | multiple sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive | Product Name: n-acetylcysteine INN or Proposed INN: Acetylcysteine | ISTITUTO C. MONDINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 101 | 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 | ||
| 102 | 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 | ||
| 103 | EUCTR2006-003037-32-DE (EUCTR) | 13/04/2007 | 01/12/2006 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 104 | 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 | ||
| 105 | EUCTR2006-002633-20-IT (EUCTR) | 26/03/2007 | 05/02/2007 | Randomized, 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 | Randomized, 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 | 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: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | |||
| 106 | 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 | ||
| 107 | EUCTR2006-003037-32-IT (EUCTR) | 19/03/2007 | 15/10/2007 | A TWO-ARM, RANDOMISED, DOUBLE-BLIND, CONTROL GROUP-COMPARED, MULTICENTRE, PHASE IIIB STUDY WITH MONTHLY MRI AND BIOMARKER ASSESSMENT TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF REBIF NEW FORMULATION (IFN-BETA-1A) IN SUBJECTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS - IMPROVE (INVESTIGATING MRI PARAMETERS WITH REBIF IMPROVED FORMULATION) | A TWO-ARM, RANDOMISED, DOUBLE-BLIND, CONTROL GROUP-COMPARED, MULTICENTRE, PHASE IIIB STUDY WITH MONTHLY MRI AND BIOMARKER ASSESSMENT TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF REBIF NEW FORMULATION (IFN-BETA-1A) IN SUBJECTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS - IMPROVE (INVESTIGATING MRI PARAMETERS WITH REBIF IMPROVED FORMULATION) | RELAPSING REMITTING MULTIPLE SCLEROSIS MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: Interferon beta-1a FBS-free/HSA-free, RNF INN or Proposed INN: Interferon beta-1a | MERCK SERONO INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 108 | 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 | ||
| 109 | EUCTR2006-004736-79-CZ (EUCTR) | 06/03/2007 | 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 | Czech Republic | |||
| 110 | EUCTR2006-003037-32-EE (EUCTR) | 06/03/2007 | 26/01/2007 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 111 | 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 | ||
| 112 | EUCTR2006-003037-32-ES (EUCTR) | 09/02/2007 | 10/03/2010 | Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Estonia;Spain;Lithuania;Germany;Italy | ||
| 113 | 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 | ||
| 114 | 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 | ||
| 115 | EUCTR2006-002633-20-FI (EUCTR) | 05/12/2006 | 04/09/2006 | 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 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 116 | 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 |
| 117 | NCT00441103 (ClinicalTrials.gov) | December 2006 | 26/2/2007 | A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis | A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Rebif® New Formulation (IFN-beta-1a, RNF);Drug: Placebo | Merck KGaA | NULL | Completed | 18 Years | 60 Years | All | 180 | Phase 3 | Canada;Germany;Italy;Russian Federation;Spain;Switzerland |
| 118 | EUCTR2006-002633-20-NL (EUCTR) | 17/11/2006 | 10/08/2006 | 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 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 119 | EUCTR2006-002633-20-DE (EUCTR) | 25/10/2006 | 23/08/2006 | 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 | France;Finland;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy | |||
| 120 | EUCTR2006-002633-20-AT (EUCTR) | 05/10/2006 | 14/09/2006 | 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 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 121 | EUCTR2005-005985-35-CZ (EUCTR) | 22/09/2006 | 02/08/2006 | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 320 | Czech Republic;Netherlands;Italy | |||
| 122 | EUCTR2005-005985-35-IT (EUCTR) | 05/09/2006 | 15/01/2007 | 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. - ND | 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. - ND | relapsing forms of multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Code: BIRT 2584XX Product Code: BIRT 2584 XX | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Czech Republic;Netherlands;Italy | |||
| 123 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Czech Republic;Netherlands;Italy | |||
| 124 | 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 |
| 125 | NCT00463710 (ClinicalTrials.gov) | June 2005 | 19/4/2007 | Effect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With MS | Effect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With Relapsing-Remitting and Secondary-Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Avonex® monotherapy (6.0 MIU administered i.m. each week) | State University of New York at Buffalo | Biogen Idec | Completed | 18 Years | 65 Years | Both | 150 | United States | |
| 126 | EUCTR2004-003943-28-IT (EUCTR) | 19/01/2005 | 02/02/2005 | 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 subjects with an active lesion on MRI MedDRA version: 6.1;Level: PT;Classification code 10048393 | Trade Name: CITOCHINE ED IMMUNOMODULATORI Product Name: LAQUINIMOD Product Code: ABR-215062 INN or Proposed INN: LAQUINIMOD | TEVA | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy | ||||
| 127 | 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 | ||
| 128 | 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 | ||
| 129 | NCT00315367 (ClinicalTrials.gov) | September 2004 | 14/4/2006 | A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties | A Double-Blind, Crossover Trial of Aricept® in Memory-Impaired Patients With Multiple Sclerosis: A Phase IV Demonstration of Functional MRI (fMRI) as a Surrogate Marker of Brain Activity Associated With Improvement in Memory Function | Relapsing-Remitting Multiple Sclerosis | Drug: Donepezil HCI (drug) | Neurognostics | NULL | Completed | 18 Years | 65 Years | Both | 26 | Phase 4 | United States |
| 130 | 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 |
| 131 | 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 |
| 132 | NCT00176592 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI | Phase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose Gadolinium | Multiple Sclerosis | Drug: Betaseron;Drug: Copaxone | Stuart D Cook MD | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 93 | Phase 4 | United States |
| 133 | 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 |
| 134 | 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 |
| 135 | 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 |
| 136 | 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 | |||
| 137 | 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 |