13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 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 | NCT04880577 (ClinicalTrials.gov) | September 15, 2022 | 30/4/2021 | Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis | Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Fatigue | Drug: TENOFOVIR ALAFENAMIDE FUMARATE 25 Mg ORAL TABLET [VEMLIDY];Drug: Placebo | Harvard Medical School | Gilead Sciences | Not yet recruiting | 18 Years | N/A | All | 60 | Phase 2 | NULL |
| 2 | JPRN-jRCT2051210146 | 24/02/2022 | 26/12/2021 | Phase 3 Study to Evaluate Efficacy, Safety, PK, and PD of SC Natalizumab in Japanese Participants With RRMS | A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis via a Subcutaneous Route of Administration | Relapsing-Remitting Multiple Sclerosis | Participants will receive natalizumab 300 mg SC Q4W for 48 weeks. | Amir Hadi Maghzi | NULL | Pending | >= 18age old | <= 65age old | Both | 20 | Phase 3 | Japan |
| 3 | EUCTR2021-003677-66-NL (EUCTR) | 14/02/2022 | 16/12/2021 | Clemastine fumarate as a treament for eye movement disorders in patients with multiple sclerosis | Clemastine fumarate as remyelinating treatment in internuclear ophthalmoparesis and multiple sclerosis - RESTORE | Multiple sclerosis (MS)Internuclear ophthalmoparesis (INO) MedDRA version: 21.0;Level: LLT;Classification code 10080865;Term: Multiple sclerosis lesion;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Clemastine Milstein 1 mg, tabletten Product Name: Clemastine fumarate INN or Proposed INN: CLEMASTINE FUMARATE Trade Name: Fampyra 10 mg prolonged-release tablets Product Name: Fampridine INN or Proposed INN: Fampridine | Amsterdam University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 3 | Netherlands | ||
| 4 | EUCTR2021-000639-30-ES (EUCTR) | 12/01/2022 | 20/09/2021 | A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse. | A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse. | Patients with primary progressive or secondary progressive multiple sclerosis without relapse MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Canada;Poland;South Africa;Bulgaria;Germany;Sweden;Portugal;United States;Greece;Finland;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary | ||
| 5 | NCT05177718 (ClinicalTrials.gov) | January 1, 2022 | 13/12/2021 | Natalizumab and Chronic Inflammation | Assessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin Integrity | Multiple Sclerosis | Drug: Natalizumab 300 MG in 15 ML Injection | Vanderbilt University Medical Center | Biogen | Recruiting | 18 Years | 65 Years | All | 36 | Phase 4 | United States |
| 6 | JPRN-jRCT2051210115 | 09/12/2021 | 29/10/2021 | A Study of Diroximel Fumarate (DRF) in Adult Participants from the Asia-Pacific Region with Relapsing Forms of Multiple Sclerosis (RMS) | An Open-Label, Single-Arm, Multicenter, Phase 3 Study to Evaluate the Safety and Tolerability, and Pharmacokinetics of Diroximel Fumarate (BIIB098) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis (RMS) | Research Name: BIIB098 (also known as ALK8700) Generic Name: Diroximel Fumarate (DRF) Trade Name: Vumerity Participants will initiate treatment with DRF 231 mg twice daily on Day 1 through Day 7, followed by 462 mg twice daily from Day 8 onwards. | Hanna Jerome Thomas | NULL | Recruiting | >= 18age old | <= 65age old | Both | 100 | Phase 3 | China;Japan |
| 7 | NCT04601233 (ClinicalTrials.gov) | December 2021 | 2/10/2020 | Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis | Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study) | Multiple Sclerosis;Erectile Dysfunction;Testosterone Deficiency | Drug: XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector | Tulane University | Louisiana State University Health Sciences Center in New Orleans;Antares Pharma Inc. | Not yet recruiting | 18 Years | N/A | Male | 20 | Phase 4 | United States |
| 8 | EUCTR2020-005947-22-IT (EUCTR) | 17/11/2021 | 12/10/2021 | Effect of siponimod on progressive multiple sclerosis | Effect of siponimod on relevant imaging and immunological hallmarks of progressive multiple sclerosis - Effect of siponimod on progressive multiple sclerosis | Active progressive MS course after an initial relapse clinical course MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg Product Code: [Siponimod] INN or Proposed INN: Siponimod Product Name: Siponimod 0,25 mg Product Code: [Siponimod] INN or Proposed INN: Siponimod Product Name: Siponimod 1 mg Product Code: [Siponimod] INN or Proposed INN: Siponimod | AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Italy | ||
| 9 | EUCTR2020-004128-41-IT (EUCTR) | 11/10/2021 | 07/10/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS - Operetta 2 | 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: GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE Product Name: N/A Product Code: [N/A] INN or Proposed INN: FINGOLIMOD Trade Name: GILENYA - 0.25 MG - CAPSULE RIGIDE - USO ORALE Product Name: N/A Product Code: [N/A] INN or Proposed INN: FINGOLIMOD Trade Name: Ocrevus Product Name: N/A Product Code: [N/A] INN or Proposed INN: Ocrelizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 10 | EUCTR2020-004505-32-IT (EUCTR) | 24/09/2021 | 12/10/2021 | Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients | An Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mgSC monthly vs. First Line DMT - physician’s choice in the treatment of newly diagnosed RMS (STHENOS) - STHENOS | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE 28 SIRINGHE PRERIEMPITE Product Name: COPAXONE Product Code: [-] INN or Proposed INN: glatiramer acetato Trade Name: Rebif Product Name: Rebif Product Code: [-] INN or Proposed INN: interferone beta-1a Trade Name: Rebif Product Name: rebif Product Code: [-] INN or Proposed INN: interferone beta-1a Trade Name: plegridy Product Name: plegridy Product Code: [-] INN or Proposed INN: peginterferone beta 1a Trade Name: Avonex Product Name: Avonex Product Code: [-] INN or Proposed INN: Interferone beta 1a Trade Name: Extavia Product Name: Extavia Product Code: [-] INN or Proposed INN: interferone beta-1b Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Germany;Italy | ||
| 11 | EUCTR2020-002700-39-PT (EUCTR) | 03/09/2021 | 24/05/2021 | Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis. | A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS | Multiple Sclerosis in pediatric patients MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta 20 mg solution for injection in pre-filled pen Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Mayzent 2 mg film-coated tablets Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Product Name: Siponimod Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: SIPONIMOD FUMARIC ACID Trade Name: Mayzent 0.25 mg fi | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany | ||
| 12 | NCT04909502 (ClinicalTrials.gov) | September 2021 | 14/5/2021 | Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis | A Phase II, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 | Relapsing Forms of Multiple Sclerosis | Drug: EHP-101 25 mg OD;Drug: EHP-101 25 mg BID;Drug: EHP-101 50 mg OD;Drug: EHP-101 50 mg BID | Emerald Health Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 55 Years | All | 50 | Phase 2 | NULL |
| 13 | NCT05049161 (ClinicalTrials.gov) | August 27, 2021 | 31/8/2021 | A Long-term Extension of Study GNC-401 | A Long-term Extension of Study GNC-401 With Temelimab in Patients With Relapsing Forms of Multiple Sclerosis (RMS) Under Treatment With Rituximab | Multiple Sclerosis | Drug: Temelimab 18 mg/kg;Drug: Temelimab 36mg/kg;Drug: Temelimab 54 mg/kg | GeNeuro Innovation SAS | NULL | Recruiting | 18 Years | 55 Years | All | 40 | Phase 2 | Sweden |
| 14 | EUCTR2020-003271-18-ES (EUCTR) | 01/07/2021 | 05/07/2021 | A trial to test how efficient Nabiximols is for treatment of spacticity in patients with Multiple Sclerosis | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis | Symptomatic treatment of spasticity in patients with multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sativex 2,7mg/2,5 mg Solucion para pulverizacion bucal Product Name: Nabiximols - Sativex INN or Proposed INN: Tetrahydrocannabinol Botanical Drug Substance (THC BDS) Other descriptive name: DELTA-9-TETRAHYDROCANNABINOL INN or Proposed INN: Cannabidiol Botanical Drug Substance (CBD BDS) Other descriptive name: CANNABIDIOL | GW Pharma Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | Phase 3 | Czechia;Czech Republic;Poland;Belgium;Spain;Australia;United Kingdom;Sweden | ||
| 15 | NCT04940065 (ClinicalTrials.gov) | June 30, 2021 | 22/6/2021 | Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen | Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen (Relapsing-remitting Multiple Sclerosis and Active Secondary Progressive Multiple Sclerosis) | Relapsing-remitting Multiple Sclerosis;Active Secondary Progressive Multiple Sclerosis | Other: Kesimpta | Novartis Pharmaceuticals | NULL | Recruiting | N/A | 99 Years | All | 330 | Japan | |
| 16 | NCT04878211 (ClinicalTrials.gov) | June 10, 2021 | 3/5/2021 | A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab | An Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously | Relapsing Multiple Sclerosis (RMS) | Drug: Ofatumumab;Biological: mRNA COVID-19 vaccine;Drug: interferon or glatiramer acetate | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 66 | Phase 4 | United States |
| 17 | NCT04847596 (ClinicalTrials.gov) | May 21, 2021 | 14/4/2021 | A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab | An Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously | Relapsing Multiple Sclerosis | Other: Ofatumumab;Other: Covid-19 vaccine | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 22 | United States;Puerto Rico | |
| 18 | EUCTR2020-003995-42-IT (EUCTR) | 13/05/2021 | 04/06/2021 | Extension to the MAGNIFY MS trial on Mavenclad® | A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE Product Name: Cladribine tablets Product Code: [Not Applicable] INN or Proposed INN: CLADRIBINA | MERCK KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 4 | Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany;Italy | ||
| 19 | EUCTR2021-000307-20-DE (EUCTR) | 28/04/2021 | 12/02/2021 | Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS) | Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS) | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: Kesimpta 20 mg Injektionslösung im Fertigpen Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Comirnaty Konzentrat zur Herstellung einer Injektionsdispersion INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified) Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Trade Name: Spikevax INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) | Novartis Pharma Vertriebs GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Germany | ||
| 20 | EUCTR2020-005752-38-DE (EUCTR) | 18/03/2021 | 19/01/2021 | An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC) | An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC) | secondary progressive multiple sclerosis (SPMS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mayzent 2 mg Filmtabletten Product Name: Mayzent 2 mg Filmtabletten Product Code: BAF312A INN or Proposed INN: SIPONIMOD Other descriptive name: Siponimod Trade Name: Mayzent 0,25 mg Filmtabletten Product Name: Mayzent 0,25 mg Filmtabletten Product Code: BAF312A INN or Proposed INN: SIPONIMOD Other descriptive name: Siponimod Trade Name: Spikevax INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE INN or Proposed INN: TERIFLUNOMIDE INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE INN or Proposed INN: RECOMBINANT INTERFERON BE | Novartis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Germany | ||
| 21 | JPRN-jRCT2031200333 | 02/03/2021 | 29/01/2021 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | Neuromyelitis Optica Spectrum Disorder (NMOSD) | Satralizumab: 120 mg SC injection every 4 weeks (Q4W) | Hans-Christian von Buedingen | NULL | Not Recruiting | Not applicable | Not applicable | Both | 127 | Phase 4 | Italy;Taiwan;United States;Poland;Canada;United Kingdom;Ukraine;Bulgaria;Turkey;Korea;Romania;Georgia;Malaysia;Croatia;Hungary;Spain;Germany;Japan |
| 22 | NCT04667949 (ClinicalTrials.gov) | February 20, 2021 | 8/12/2020 | Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients | A 24-month, Open-label, Prospective, Multicenter Interventional, Single-arm Study Assessing the Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Relapsing Multiple Sclerosis (RMS) Patients in China | Relapsing Multiple Sclerosis (RMS) | Drug: Fingolimod 0.5mg | Novartis Pharmaceuticals | NULL | Recruiting | 10 Years | 65 Years | All | 100 | Phase 4 | China |
| 23 | EUCTR2019-004857-10-PT (EUCTR) | 09/02/2021 | 14/12/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing multiple sclerosis (RMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Trade Name: Aubagio 14 mg film-coated tablets Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | United States;France;Portugal;Finland;Germany;Netherlands | ||
| 24 | NCT04667117 (ClinicalTrials.gov) | January 14, 2021 | 8/12/2020 | A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab | An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously | Relapsing Multiple Sclerosis | Biological: Quadrivalent influenza vaccine;Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 66 | Phase 4 | United States |
| 25 | EUCTR2020-003874-30-IT (EUCTR) | 08/01/2021 | 24/05/2021 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE Product Name: Cladribine tablets Product Code: [Not Applicable] INN or Proposed INN: CLADRIBINA | MERCK KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 4 | France;Czechia;Hungary;Slovakia;Spain;Poland;Denmark;Austria;Netherlands;Italy | ||
| 26 | JPRN-jRCT2051210017 | 15/10/2020 | 07/05/2021 | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | This study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects. | Sato Toshiyuki | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 7 | Phase 3 | Japan |
| 27 | EUCTR2017-003008-30-GB (EUCTR) | 01/07/2020 | 17/05/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A double-blind, randomised, placebo-controlled single-site study of high dose simvastatin treatment for secondary progressive multiple sclerosis: impact on vascular perfusion and oxidative damage - MS-OPT Version 1.3 dated 23/05/18 | Multiple Sclerosis (Secondary Progressive) MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets Product Code: Not applicable INN or Proposed INN: Simvastatin | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | ||
| 28 | EUCTR2019-001829-26-IT (EUCTR) | 19/06/2020 | 22/01/2021 | A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD). | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder. - NA | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML) Product Name: Soliris Product Code: [Soliris] INN or Proposed INN: ECULIZUMAB Trade Name: MENVEO Product Name: MENVEO Product Code: [NA] Other descriptive name: N. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197 Trade Name: Bexsero Product Name: Bexsero Product Code: [NA] Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN Trade Name: Hiberix Product Name: Hiberix Product Code: [NA] Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) Trade Name: Prevenar 13 Product Name: Prevenar 13 Product Code: [NA] Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2;Phase 3 | United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 29 | NCT04480307 (ClinicalTrials.gov) | June 17, 2020 | 10/7/2020 | Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis | A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS) | Multiple Sclerosis | Drug: temelimab 18 mg/kg;Drug: temelimab 36 mg/kg;Drug: temelimab 54 mg/kg;Drug: Placebo | GeNeuro Innovation SAS | NULL | Active, not recruiting | 18 Years | 55 Years | All | 41 | Phase 2 | Sweden |
| 30 | NCT04410965 (ClinicalTrials.gov) | May 20, 2020 | 28/5/2020 | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks | Multiple Sclerosis | Drug: TERIFLUNOMIDE | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 82 | Phase 4 | China |
| 31 | NCT04267926 (ClinicalTrials.gov) | April 1, 2020 | 11/2/2020 | MitoQ for Fatigue in Multiple Sclerosis (MS) | MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial | Multiple Sclerosis;Fatigue | Drug: 20 mg MitoQ;Drug: Placebo;Drug: 40mg of MitoQ | VA Office of Research and Development | NULL | Recruiting | 18 Years | 70 Years | All | 60 | Phase 1/Phase 2 | United States |
| 32 | EUCTR2018-000001-23-CZ (EUCTR) | 13/01/2020 | 16/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol 25 mg/ml, oral drops Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Not Recruiting | Female: yes Male: yes | 548 | Phase 3 | Hungary;Czech Republic;Spain | ||
| 33 | EUCTR2019-003001-94-SK (EUCTR) | 06/11/2019 | 13/09/2019 | Use of GLP-1 analogs in the treatment of multiple sclerosis | Use of GLP-1 analogs in the treatment of multiple sclerosis - MSGLP | Our hypothesis is that patients with MS have a disorder of energy metabolism in neurons and glial cells of the CNS, contributing to the development and progression of demyelinating foci and neurodegeneration, and manifested by insulin resistance in both peripheral tissues and the CNS. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere. Product Name: Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere | Lekárska fakulta UK Bratislava | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Slovakia | ||
| 34 | 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 |
| 35 | JPRN-JapicCTI-205119 | 15/10/2019 | 20/01/2020 | A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients | A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients | neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD) | Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Chugai Pharmaceutical Co., Ltd. | F. Hoffmann-La Roche Ltd | complete | 12 | 74 | BOTH | 30 | NA | Japan |
| 36 | NCT04129736 (ClinicalTrials.gov) | October 10, 2019 | 15/10/2019 | Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis | Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily. | Multiple Sclerosis, Pharmacokinetics | Drug: Teriflunomide 14 MG | Jan Lycke | NULL | Recruiting | 18 Years | 65 Years | All | 12 | Phase 4 | Sweden |
| 37 | ChiCTR1900025744 | 2019-09-01 | 2019-09-07 | Clinical effectiveness and safety of Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial | Clinical effectiveness and safety Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial | neuromyelitis optica spectrum disorder (NMOSD) | 1:Intravenous 200mg Rituximab, 1/week*2, if the proportion of CD19+ B lymphocytes in peripheral blood is above 1% then repeat administration (200mg);2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (750~3000mg/day); | The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital | NULL | Recruiting | 18 | 70 | Both | 1:30;2:30; | Phase 4 | China |
| 38 | JPRN-JapicCTI-194838 | 31/7/2019 | 02/07/2019 | Investigation for immune response against JC virus in Multiple Sclerosis patients on treatment with fingolimod | A 18-month, multicenter, two-cohort, prospective, observational study to investigate immune response against JC virus in Multiple Sclerosis patients on treatment with 0.5 mg fingolimod (FTY720) | Multiple Sclerosis | Intervention name : Gilenya / Imusera INN of the intervention : Fingolimod Dosage And administration of the intervention : 0.5mg/day Fingolimod orally Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Novartis Pharma K.K. | Mitsubishi Tanabe Pharma Corporation | recruiting | 18 | BOTH | 280 | NA | Japan | |
| 39 | EUCTR2018-004557-24-DE (EUCTR) | 29/07/2019 | 18/06/2019 | Clarifying the mechanism of action of cladribine in relapsing multiple sclerosis | Clarifying the mechanism of action of cladribine in relapsing multiple sclerosis - ClaiMS, Cladribine in MS | Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD 10 mg tablets INN or Proposed INN: CLADRIBINE | Westfälische Wilhelms-Universität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Recht u. Drittmittel | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Germany | ||
| 40 | EUCTR2019-001505-24-NO (EUCTR) | 25/07/2019 | 28/05/2019 | A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple Sclerosis | Norwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS | Relapsing Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rituximab konsentrat til infusjonsvaeske oppløsning 10 mg/ml Product Name: Rituximab Trade Name: Mavenclad tabletter 10 mg Product Name: Cladribine | Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Norway | ||
| 41 | NCT04056897 (ClinicalTrials.gov) | June 7, 2019 | 12/8/2019 | Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis | International Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: BCD-132, 125 mg;Drug: Teriflunomide;Drug: Placebo;Biological: BCD-132, 500 mg | Biocad | NULL | Active, not recruiting | 18 Years | 60 Years | All | 270 | Phase 2 | Russian Federation |
| 42 | EUCTR2017-001294-16-DE (EUCTR) | 18/02/2019 | 07/11/2018 | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) INN or Proposed INN: Not available Other descriptive name: Diroximel fumarate Trade Name: Tecfidera® 120 mg Product Name: Tecfidera® 120 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240 mg Product Name: Tecfidera® 240 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Poland;Germany | ||
| 43 | 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 |
| 44 | EUCTR2017-004702-17-PL (EUCTR) | 25/01/2019 | 17/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 45 | EUCTR2017-005129-18-IT (EUCTR) | 08/01/2019 | 26/03/2018 | Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis. | Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis. | Relapsing-remitting multiple sclerosis with paediatric onset MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 40 mg/ml solution for injection, pre-filled syringe INN or Proposed INN: Glatiramer Acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: AVONEX 30 µg/0,5 ml solution for injection INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Università degli Studi Aldo Moro | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Italy | ||
| 46 | EUCTR2017-004702-17-ES (EUCTR) | 12/12/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 284 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 47 | EUCTR2018-002315-98-DK (EUCTR) | 06/12/2018 | 09/07/2018 | The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury. | The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI | Central neuropathic pain and spasticity MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10077975;Term: Central neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cannabidiol capsule 5 mg Product Code: N/A INN or Proposed INN: Cannabidiol Other descriptive name: CBD Product Name: Dronabinol capsule 2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg Product Code: N/A INN or Proposed INN: DRONABINOL Other descriptive name: THC INN or Proposed INN: Cannabidiol Other descriptive name: CBD | Aarhus Universitetshospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 448 | Phase 2 | Denmark | ||
| 48 | EUCTR2017-004702-17-BG (EUCTR) | 03/12/2018 | 23/10/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 49 | EUCTR2017-004702-17-IT (EUCTR) | 07/11/2018 | 04/11/2020 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND | Multiple sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE Product Name: Formistin 10 mg Product Code: [Formistin 10 mg] Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [Tachipirina CPR 500mg] Other descriptive name: paracetamolo 500 mg Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Solumedrol IM 125mg/2ml Product Code: [Metilprednisolone] Other descriptive name: Metilprednisolone sodio succinato Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: Ofatumumab Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: OFATUMUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia | ||
| 50 | EUCTR2017-004702-17-LV (EUCTR) | 02/11/2018 | 03/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy | ||
| 51 | EUCTR2017-004702-17-LT (EUCTR) | 31/10/2018 | 17/09/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 52 | EUCTR2018-000001-23-HU (EUCTR) | 25/10/2018 | 16/08/2018 | Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosis | A phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS | Symptomatic relief of spasticity in patients with multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dronabinol 25 mg/ml, oral drops Product Code: BX-1 INN or Proposed INN: Dronabinol Other descriptive name: Dronabinol | Bionorica SE | NULL | Not Recruiting | Female: yes Male: yes | 548 | Phase 3 | Czech Republic;Hungary;Spain | ||
| 53 | EUCTR2017-004702-17-CZ (EUCTR) | 23/10/2018 | 16/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 54 | EUCTR2016-004719-10-GR (EUCTR) | 15/10/2018 | 24/07/2018 | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | Relapsing multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Serbia;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 55 | EUCTR2017-004702-17-EE (EUCTR) | 17/09/2018 | 28/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 56 | NCT03560739 (ClinicalTrials.gov) | September 11, 2018 | 15/5/2018 | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients | Multiple Sclerosis | Combination Product: ofatumumab with PRF;Combination Product: ofatumumab with AI | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 284 | Phase 2 | United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain |
| 57 | EUCTR2017-004702-17-AT (EUCTR) | 01/09/2018 | 10/08/2018 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy | ||
| 58 | NCT03589105 (ClinicalTrials.gov) | August 6, 2018 | 5/7/2018 | A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting | An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mg | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 423 | Phase 4 | France |
| 59 | EUCTR2016-004719-10-FI (EUCTR) | 25/07/2018 | 12/06/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | Relapsing multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Romania;Bulgaria;Georgia;Germany;Sweden;Croatia;Poland;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Finland;Czechia;Bosnia and Herzegovina;Latvia;France;Italy;Israel;Russian Federation;Ukraine;Spain;Greece;Portugal;Belarus;Serbia;United States | ||
| 60 | NCT03567057 (ClinicalTrials.gov) | July 18, 2018 | 22/5/2018 | A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment | A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment | Multiple Sclerosis;Walking Impairment | Drug: ADS-5102, 274 mg | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 424 | Phase 3 | United States;Canada |
| 61 | EUCTR2018-000721-31-SE (EUCTR) | 04/07/2018 | 24/04/2018 | A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis. | RItuximab Long-Term DOSE Trial in Multiple Sclerosis – RIDOSE-MSA randomized trial of long-term dosage of rituximab in multiple sclerosisThe RIDOSE-MS trial is a multi-centre trial of long-term treatment with rituximab in MS, randomised between two different dosing regimens. Population: Patients with RRMS that has completed the RIFUND-MS trial in either the rituximab or DMF arm. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Intervention: Treatment with rituximab (Mabthera®) 500 mg every six months. Both the previous rituximab and DMF arms from the RIFUND trial will be treated with rituximab in the RIDOSE trial.Control: After one year of treatment in RIDOSE-MS, patients will be randomised 1:1 to either continue with 500 mg every 6 months or 500 mg every 12 months and continue on this treatment schedule for another 3 years.Outcome: Primary outcome will be the proportion of patients remaining with no evidence of disease activity (NEDA) -3 over the randomised period of 3 years. As secondary endpoints progression of disability, brain atrophy, cognitive function and level of serum Neurofilament-Light will be evaluated. In addition, Patient-related outcome scales measuring fatigue, work ability and treatment satisfaction will be analysed. - RIDOSE-MS | Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB | Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Sweden | ||
| 62 | EUCTR2016-004719-10-PT (EUCTR) | 02/07/2018 | 12/02/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 63 | NCT03498131 (ClinicalTrials.gov) | May 9, 2018 | 6/4/2018 | Melatonin in Patients With Multiple Sclerosis (MS). | Evaluating the Potential Role of Melatonin in Subjects With Relapsing Multiple Sclerosis (MS) | Relapsing Remitting Multiple Sclerosis | Drug: 3 mg Melatonin;Drug: 5 mg Melatonin | Providence Health & Services | NULL | Active, not recruiting | 18 Years | 65 Years | All | 30 | Early Phase 1 | United States |
| 64 | EUCTR2016-004719-10-GB (EUCTR) | 26/04/2018 | 22/05/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 65 | EUCTR2018-000780-91-FR (EUCTR) | 26/04/2018 | 30/03/2018 | STUDY TO ASSESS OCRELIZUMAB EFFICACY, SAFETY AND IMPACT ON PATIENT REPORTED OUTCOMES (PROS) IN PATIENTS WITH ACTIVE RELAPSING MULTIPLE SCLEROSIS(PRO-MSACTIVE) | AN OPEN-LABEL, SINGLE-ARM PHASE IV STUDY TO ASSESS OCRELIZUMAB EFFICACY, SAFETY AND IMPACT ON PATIENT REPORTED OUTCOMES (PROS) IN PATIENTS WITH ACTIVE RELAPSING MULTIPLE SCLEROSIS(PRO-MSACTIVE) - PRO-MSActive | ACTIVE RELAPSING MULTIPLE SCLEROSIS (Active RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;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: Ocrevus 300 mg, solution à diluer pour perfusion Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 570 | Phase 4 | France | ||
| 66 | NCT03436199 (ClinicalTrials.gov) | March 29, 2018 | 12/2/2018 | Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment | A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment | Walking Impairment;Multiple Sclerosis | Drug: ADS-5102, 137 mg;Drug: ADS-5102, 274 mg;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 70 Years | All | 558 | Phase 3 | United States;Canada |
| 67 | EUCTR2016-004719-10-HR (EUCTR) | 27/03/2018 | 12/04/2018 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 68 | JPRN-JapicCTI-173711 | 15/3/2018 | 14/09/2017 | Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab | A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab | Relapsing Multiple Sclerosis | Intervention name : Ofatumumab INN of the intervention : - Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks | Novartis Pharma K.K. | NULL | complete | 18 | 55 | BOTH | 30 | Phase 2 | Japan, Russia |
| 69 | EUCTR2016-004414-10-SE (EUCTR) | 23/02/2018 | 02/01/2018 | Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily. | Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily. | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | MS Centrum, Department of Neurology, Sshlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Sweden | ||
| 70 | EUCTR2016-004719-10-LV (EUCTR) | 30/01/2018 | 10/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 71 | NCT03330418 (ClinicalTrials.gov) | January 29, 2018 | 31/10/2017 | A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders | A Phase III Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Neuromyelitis Optica Spectrum Disorders. | Neuromyelitis Optica Spectrum Disorders | Biological: Placebo;Biological: RC18 160 mg | RemeGen Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 166 | Phase 3 | China |
| 72 | EUCTR2016-004719-10-BG (EUCTR) | 24/01/2018 | 01/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Belarus;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 73 | EUCTR2016-004719-10-CZ (EUCTR) | 22/01/2018 | 29/09/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis. - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 74 | EUCTR2016-004719-10-HU (EUCTR) | 11/01/2018 | 20/11/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 75 | EUCTR2016-004819-12-IT (EUCTR) | 10/01/2018 | 20/01/2022 | Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients | Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders | Relapsing-Remitting multiple sclerosis (RR-MS), MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 ML Product Name: Interferone Beta-1B Product Code: [032166011] INN or Proposed INN: INTERFERONE BETA 1B Other descriptive name: Interferon Beta-1B Trade Name: AVONEX - 30 MCG (6 MILIONI UI) POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 4 FLACONI CON DISPOSITIVO BIOSET + 4 SIRINGHE PRERIEMPITE USO INTRAMUSCOLARE Product Name: Inteferone Beta-1A Product Code: [033283045] INN or Proposed INN: INTERFERON BETA - 1A Other descriptive name: Interferon Beta 1-A Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO Product Name: Glatiramer acetato Product Code: [035418060] INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: Glatiramer acetate Trade Name: REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML)12 PENNE PRERIEMPITE Product Name: Interferon Beta-1a Product Code: [034091165] INN or Proposed INN: INTERFERON BETA - 1A Other descriptive name: Interferon Beta-1a | OSPEDALE SAN RAFFAELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 4 | Italy | ||
| 76 | EUCTR2016-004719-10-LT (EUCTR) | 29/12/2017 | 04/12/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 77 | EUCTR2017-003328-56-GB (EUCTR) | 19/12/2017 | 31/10/2017 | MS-STAT2 - Multiple Sclerosis – Simvastatin Trial 2 | A phase 3 randomised, double blind, clinical trial investigating the effectiveness of repurposed simvastatin compared to placebo, in secondary progressive multiple sclerosis, in slowing the progression of disability - MS-STAT2 | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets INN or Proposed INN: Simvastatin Trade Name: Simvastatine Sandoz 40 mg filmomhulde tabletten Product Name: Simvastatine Sandoz 40 mg filmomhulde tabletten INN or Proposed INN: Simvastatin Trade Name: SimvaHEXAL® 40 mg Filmtabletten Product Name: SimvaHEXAL® 40 mg Filmtabletten INN or Proposed INN: Simvastatin Trade Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG Product Name: Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG INN or Proposed INN: Simvastatin Trade Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película Product Name: Sinvastatina Sandoz 40 mg comprimidos revestidos por película INN or Proposed INN: Simvastatin Trade Name: Sivatin 40 mg film-coated tablets Product Name: Sivatin 40 mg film-coated tablets INN or Proposed INN: Simvastatin Trade Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten Product Name: Simvastatine Sandoz 40mg deelbare filmomhulde tabletten INN or Proposed INN: Simvastatin | University College London Comprehensive Clinical Trials Unit | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1180 | Phase 3 | United Kingdom | ||
| 78 | NCT03362294 (ClinicalTrials.gov) | December 11, 2017 | 15/11/2017 | Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS | A Prospective, Multicenter, Two Arms, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 25 mg or 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS) | Primary Progressive Multiple Sclerosis | Drug: GA Depot 40mg once monthly;Drug: GA Depot 25mg once monthly | Mapi Pharma Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 30 | Phase 2 | Israel;Moldova, Republic of |
| 79 | EUCTR2016-004719-10-PL (EUCTR) | 02/12/2017 | 24/08/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 80 | EUCTR2015-005431-41-PL (EUCTR) | 16/10/2017 | 07/04/2016 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of | ||
| 81 | EUCTR2016-004719-10-SE (EUCTR) | 04/10/2017 | 28/07/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PO | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Serbia;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Czechia;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Sweden | ||
| 82 | EUCTR2016-004719-10-ES (EUCTR) | 02/10/2017 | 04/07/2017 | A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis. | Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis - OPTIMUM LT | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 83 | NCT03122652 (ClinicalTrials.gov) | September 25, 2017 | 12/4/2017 | Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome | Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study | Multiple Sclerosis | Drug: Teriflunomide 14 MG Oral Tablet [Aubagio];Drug: Placebo Oral Tablet | Centre Hospitalier Universitaire de Nice | Genzyme, a Sanofi Company | Active, not recruiting | 18 Years | N/A | All | 125 | Phase 3 | France;Switzerland;Turkey;Germany;Martinique;Sweden;United Kingdom |
| 84 | EUCTR2017-001294-16-PL (EUCTR) | 22/09/2017 | 29/06/2017 | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate | Relapsing-Remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N/A Product Code: ALKS 8700 Delayed Release (DR) INN or Proposed INN: Not available Other descriptive name: Diroximel Fumarate (DRF) Trade Name: Tecfidera® 120 mg Product Name: Tecfidera® 120 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE Trade Name: Tecfidera® 240 mg Product Name: Tecfidera® 240 mg INN or Proposed INN: Tecfidera Other descriptive name: DIMETHYL FUMARATE | Alkermes, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Poland;Germany | ||
| 85 | EUCTR2017-000559-26-IT (EUCTR) | 14/09/2017 | 30/09/2021 | A multicentric, international study in order to compare the effectiveness of fingolimod versus dimethyl-fumarate on patients with Multiple Sclerosis. | A multicentric randomized PRAGmatic trial to compare the effectiveness of fingolimod versus dimethyl-fumarate on patient overall disease experience in relapsing remitting Multiple Sclerosis: novel data to inform decision-makers – (PRAG-MS) - PRAG-MS | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE - BLISTER DIVISIBILE PER DOSE UNITARIA(PVC/PVDC/ALU) SCATOLA DA 7X1 CAPSULE INN or Proposed INN: FINGOLIMOD Trade Name: TECFIDERA - 240 MG - CAPSULA RIGIDA GASTRORESISTENTE - USO ORALE - BLISTER (PVC/PE/PVDC-PVC ALLUMINIO) - 56 CAPSULE INN or Proposed INN: DIMETIL-FUMARATO | FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1360 | Phase 4 | United States;Israel;Switzerland;Italy | ||
| 86 | NCT03232073 (ClinicalTrials.gov) | July 5, 2017 | 20/7/2017 | Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis | Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ponesimod | Actelion | NULL | Active, not recruiting | 18 Years | 65 Years | All | 877 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom |
| 87 | EUCTR2015-005419-33-IT (EUCTR) | 09/05/2017 | 25/05/2021 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis - Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing form | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: ARZERRA - 100 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONE(VETRO) - 5 ML(20MG/ML) 3 FLACONI Product Name: ofatumumab Product Code: [OMB 157] INN or Proposed INN: Ofatumumab Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BISTER (ALU/ALU) PERFORATO MONODOSE - 10 X 1 COMPRESSA Product Name: Teriflunomide Product Code: [NA] INN or Proposed INN: Teriflunomide Other descriptive name: Aubagio | NOVARTIS PHARMA SERVICES AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Italy;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 88 | EUCTR2015-005418-31-IT (EUCTR) | 09/05/2017 | 09/11/2020 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis - Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing form | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: ARZERRA - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 50 ML (20 MG/ML) 1 FLACONCINO + 2 KIT DI PROLUNGA Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BISTER (ALU/ALU) PERFORATO MONODOSE - 10 X 1 COMPRESSA Product Name: Teriflunomide Product Code: [NA] INN or Proposed INN: Teriflunomide | NOVARTIS PHARMA SERVICES AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 89 | NCT04570670 (ClinicalTrials.gov) | January 6, 2017 | 22/9/2020 | Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects | A Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting Conditions | Relapsing Remitting Multiple Sclerosis | Drug: monomethyl fumarate 190 mg;Drug: dimethyl fumarate 240 mg | Banner Life Sciences LLC | NULL | Completed | 18 Years | 55 Years | All | 50 | Phase 1 | NULL |
| 90 | EUCTR2015-005431-41-HR (EUCTR) | 30/11/2016 | 15/12/2016 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 3 | United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of | ||
| 91 | EUCTR2016-001515-20-IT (EUCTR) | 20/10/2016 | 07/02/2018 | nd | EFFECT OF TERIFLUNOMIDE ON T CELL SUBPOPULATIONS INPERIPHERAL BLOOD FROM RRMS PATIENTS - nd | RELAPSING-REMITTING MULTIPLE SCLEROSIS MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) - 28 COMPRESSE Product Name: teriflunomide Product Code: nd | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Italy | ||
| 92 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 93 | EUCTR2016-000708-26-IT (EUCTR) | 23/09/2016 | 22/06/2021 | ND | Evaluation of clinical response in relation to the immunological status change in RRMS patients treated with Gilenya (fingolimod) for 12 months. - nd | 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: GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE - BLISTER(PVC/PVDC/ALU) SCATOLA DA 28 CAPSULE Product Name: Fingolimod | FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | Italy | ||
| 94 | JPRN-UMIN000024312 | 2016/09/20 | 25/05/2017 | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. | Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis | Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks | Tsukuba International Clinical Pharmacology Clinic | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 12 | Not selected | Japan | |
| 95 | EUCTR2016-001356-22-HU (EUCTR) | 13/07/2016 | 26/04/2016 | A STUDY OF THE SAFETY AND EFFECTS OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH TIGHTNESS, STIFFNESS AND PULL OF MUSCLES DUE TO MULTIPLE SCLEROSIS | A PLACEBO-CONTROLLED RANDOMIZED WITHDRAWAL EVALUATION OF THE EFFICACY AND SAFETY OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH SPASTICITY DUE TO MULTIPLE SCLEROSIS | Spasticity due to multiple sclerosis MedDRA version: 19.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 10 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Baclofen Tablets USP Product Name: Baclofen Tablets USP 10 mg INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 20 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 30mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 40mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN Trade Name: Liofen XL Product Name: Baclofen ER Capsules (GRS) 50 mg Product Code: SPARC0921 INN or Proposed INN: BACLOFEN | Sun Pharma Advanced Research Company Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Hungary;Ukraine;Russian Federation;Germany | ||
| 96 | EUCTR2014-004650-34-IT (EUCTR) | 27/06/2016 | 05/11/2020 | New strategies for diagnostic, therapeutic and clinical care in neurological diseases | Neuromodulation strategies to enhance the effects of gait rehabilitation in multiple sclerosis patients with cerebellar ataxia - New strategies in neurological diseases | Multiple sclerosis with cerebellar ataxia MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FAMPYRA - 10 MG - COMPRESSA A RILASCIO PROLUNGATO - USO ORALE - FLACONE (HDPE) 56 COMPRESSE (4 FLACONI DA 14) INN or Proposed INN: FAMPRIDINA Other descriptive name: 4-aminopyridine | IRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 4 | Italy | ||
| 97 | NCT02720107 (ClinicalTrials.gov) | May 12, 2016 | 21/3/2016 | Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01) | Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720) | Relapsing-remitting Multiple Sclerosis | Drug: fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 133 | Phase 4 | Germany |
| 98 | NCT02575365 (ClinicalTrials.gov) | February 16, 2016 | 12/10/2015 | Effect of Fingolimod on Neurodegeneration | Effect of Fingolimod on Neurodegeneration, Brain Atrophy and Cognitive Impairment in Relapsing Remitting Multiple Sclerosis Patients | Cognition;Brain Volume Loss | Drug: 0,5 mg Fingolimod | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 4 | Phase 4 | Turkey |
| 99 | EUCTR2015-000922-12-DE (EUCTR) | 12/02/2016 | 02/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 100 | EUCTR2015-000922-12-FR (EUCTR) | 28/01/2016 | 26/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 101 | EUCTR2015-000922-12-ES (EUCTR) | 12/01/2016 | 13/01/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 820 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 102 | EUCTR2015-000922-12-PL (EUCTR) | 05/01/2016 | 03/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 103 | EUCTR2015-000922-12-BE (EUCTR) | 04/01/2016 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 104 | EUCTR2015-000922-12-IE (EUCTR) | 22/12/2015 | 09/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 105 | EUCTR2015-004116-38-SE (EUCTR) | 18/12/2015 | 20/10/2015 | A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis. | RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed. | Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Department of Clinical Sciences, Danderyd Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Sweden | ||
| 106 | NCT02587195 (ClinicalTrials.gov) | December 18, 2015 | 22/9/2015 | A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period | A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period | Multiple Sclerosis | Drug: Teriflunomide | Centre Hospitalier Universitaire de Nice | NULL | Unknown status | 18 Years | 55 Years | All | 5 | Phase 3 | France |
| 107 | EUCTR2015-000922-12-FI (EUCTR) | 15/12/2015 | 07/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 108 | EUCTR2015-000922-12-HR (EUCTR) | 11/12/2015 | 04/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 109 | JPRN-JapicCTI-153058 | 24/11/2015 | 04/11/2015 | Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple Sclerosis | Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple Sclerosis | Multiple sclerosis | Intervention name : Copaxone subcutaneous injection syringe Dosage And administration of the intervention : For adults, a 20 mg dose of glatiramer acetate will be subcutaneously administered once daily.Participants will receive interventions as part of routine medical care. | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | recruiting | BOTH | 1000 | NA | NULL | ||
| 110 | EUCTR2015-000922-12-AT (EUCTR) | 19/11/2015 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 111 | EUCTR2015-000922-12-IT (EUCTR) | 05/11/2015 | 28/02/2018 | A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: GLATIRAMER ACETATO | TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 112 | EUCTR2010-021219-17-BG (EUCTR) | 27/10/2015 | 13/11/2013 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;South Africa;Tunisia;Germany;Bosnia and Herzegovina | ||
| 113 | EUCTR2012-003056-36-FR (EUCTR) | 06/10/2015 | 19/06/2013 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 114 | NCT02499900 (ClinicalTrials.gov) | August 10, 2015 | 1/7/2015 | CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily | CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily | Multiple Sclerosis | Drug: Copaxone® | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | N/A | All | 861 | Phase 4 | United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey |
| 115 | EUCTR2014-001579-30-NL (EUCTR) | 21/05/2015 | 26/11/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Germany;Netherlands;Italy;United Kingdom | ||
| 116 | EUCTR2012-003735-32-SK (EUCTR) | 01/04/2015 | 09/04/2015 | Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. | A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment | Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany | ||
| 117 | NCT02373098 (ClinicalTrials.gov) | March 31, 2015 | 4/2/2015 | Fingolimod Effect on Cytokine and Chemokine Levels | Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod 0.5 mg | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 126 | Phase 4 | Turkey |
| 118 | EUCTR2014-001579-30-DE (EUCTR) | 20/03/2015 | 11/11/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 119 | EUCTR2013-003600-40-NL (EUCTR) | 20/02/2015 | 26/11/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland | ||
| 120 | EUCTR2015-000182-31-NL (EUCTR) | 11/02/2015 | 26/01/2015 | Study to evaluate the effects of fampridine in patients with multiple sclerosis and eye movement abnormality | A randomized, double-blind, placebo-controlled, cross-over study to assess the effects of fampridine on eye movements and nerve conduction in patients with multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO) | Multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra 10 mg prolonged-release tablets INN or Proposed INN: FAMPRIDINE | CHDR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 121 | NCT02638038 (ClinicalTrials.gov) | February 2015 | 16/12/2015 | This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for = 3 Years | A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing Remitting | Drug: INT131 | InteKrin Therapeutics, Inc. | NULL | Completed | 18 Years | 50 Years | All | 228 | Phase 2 | NULL |
| 122 | NCT02284568 (ClinicalTrials.gov) | January 12, 2015 | 31/10/2014 | A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo | A Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS) | Primary Progressive Multiple Sclerosis | Drug: Placebo;Drug: Laquinimod | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 25 Years | 55 Years | All | 374 | Phase 2 | United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 123 | EUCTR2012-005086-12-PL (EUCTR) | 07/01/2015 | 16/09/2014 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany | ||
| 124 | EUCTR2014-001579-30-ES (EUCTR) | 22/12/2014 | 23/10/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 125 | EUCTR2014-000709-10-DE (EUCTR) | 19/12/2014 | 13/10/2014 | Investigation on how alemtuzumab acts in patients with relapsing remitting multiple sclerosis. | Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential - ALAIN01 | relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: LEMTRADA 12 mg Konzentrat zur Herstellung einer Infusionslösung INN or Proposed INN: Alemtuzumab Other descriptive name: ALEMTUZUMAB | Universitätsklinikum Münster | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | Germany | ||
| 126 | EUCTR2013-003600-40-BG (EUCTR) | 04/12/2014 | 17/10/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland | ||
| 127 | EUCTR2014-001579-30-IT (EUCTR) | 04/12/2014 | 19/09/2014 | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 128 | NCT02142192 (ClinicalTrials.gov) | December 2014 | 16/5/2014 | Natalizumab Subcutaneous Immunogenicity and Safety Study | A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Terminated | 18 Years | 65 Years | Both | 2 | Phase 2 | Belgium;Denmark;Germany;Italy |
| 129 | EUCTR2014-001579-30-GB (EUCTR) | 27/11/2014 | 08/09/2014 | A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as compared to placebo | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO | Primary Progressive Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 130 | EUCTR2014-000917-30-DE (EUCTR) | 25/11/2014 | 03/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Phase 2 | Belgium;Denmark;Germany;Italy | ||
| 131 | EUCTR2013-003600-40-CZ (EUCTR) | 22/10/2014 | 19/06/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | United States;Serbia;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;United Kingdom;Switzerland;Italy | ||
| 132 | EUCTR2014-000917-30-BE (EUCTR) | 21/10/2014 | 24/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 133 | EUCTR2012-002714-40-HR (EUCTR) | 17/10/2014 | 05/11/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1410 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Slovenia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 134 | NCT02212886 (ClinicalTrials.gov) | October 2014 | 5/8/2014 | Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS | A Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: GA Depot 80 mg;Drug: GA Depot 40 mg | Mapi Pharma Ltd. | NULL | Active, not recruiting | 18 Years | 70 Years | All | 25 | Phase 1/Phase 2 | Israel |
| 135 | EUCTR2013-003600-40-GB (EUCTR) | 15/09/2014 | 08/05/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | United States;Serbia;Finland;Ukraine;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Poland;Bulgaria;Netherlands | ||
| 136 | EUCTR2013-003600-40-IT (EUCTR) | 11/09/2014 | 27/06/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;United Kingdom;Switzerland;Italy | |||
| 137 | EUCTR2013-003600-40-LT (EUCTR) | 02/09/2014 | 18/06/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Serbia;United States;Czech Republic;Switzerland;United Kingdom;Italy;Netherlands;Bulgaria;Russian Federation;Lithuania;Poland;Finland | |||
| 138 | EUCTR2014-000917-30-DK (EUCTR) | 02/09/2014 | 10/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 139 | 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 | ||||
| 140 | NCT02045732 (ClinicalTrials.gov) | September 2014 | 22/1/2014 | A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS) | A Phase 1b, Double-blinded, Placebo-controlled, Randomized Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Subjects With Multiple Sclerosis (ms) | Multiple Sclerosis | Biological: PF-06342674 0.25 mg/kg;Biological: Placebo;Biological: PF-06342674 1.5 mg/kg;Biological: PF-06342674 6.0 mg/kg | Pfizer | NULL | Terminated | 18 Years | 55 Years | All | 4 | Phase 1 | United States |
| 141 | NCT02219932 (ClinicalTrials.gov) | September 2014 | 18/8/2014 | Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects With Multiple Sclerosis (ENHANCE) | Multiple Sclerosis | Drug: fampridine;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 70 Years | All | 646 | Phase 3 | United States;Bulgaria;Czech Republic;Finland;Italy;Lithuania;Netherlands;Poland;Russian Federation;Serbia;United Kingdom;Argentina;Germany;Switzerland |
| 142 | EUCTR2013-003752-21-PL (EUCTR) | 31/08/2014 | 04/07/2014 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120mg/vial) Product Code: Satralizumab (RO5333787/Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satrazlizumab (RO5333787/ Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Hungary;Taiwan;Spain;Poland;Ukraine;Germany;Japan;Italy;United Kingdom | ||
| 143 | ChiCTR-ICR-15007177 | 2014-08-30 | 2014-05-30 | A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis | A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis | Neuromyelitis Optica associated Optic Neuritis | 1:Intravenous 100mg Rituximab, 1/week*4 ;2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (1000-1500mg/day); | The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital | NULL | Recruiting | 18 | 70 | Both | 1:30;2:30; | China | |
| 144 | EUCTR2013-003600-40-FI (EUCTR) | 05/08/2014 | 21/07/2014 | Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE) | Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 590 | Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland | |||
| 145 | EUCTR2014-000917-30-IT (EUCTR) | 25/07/2014 | 07/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 146 | EUCTR2012-000835-18-PL (EUCTR) | 22/07/2014 | 06/06/2014 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: Fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 147 | EUCTR2013-003126-83-DE (EUCTR) | 23/06/2014 | 17/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 148 | EUCTR2012-000835-18-DK (EUCTR) | 23/06/2014 | 09/05/2014 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 149 | EUCTR2012-002714-40-SK (EUCTR) | 02/06/2014 | 12/03/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 150 | NCT01941004 (ClinicalTrials.gov) | June 2014 | 9/9/2013 | Safety and Efficacy of Fingolimod in MS Patients in China | A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis (Relapsing Remitting) | Drug: fingolimod;Drug: Placebo (6mos) + open label fingolimod (6 mos) | Novartis Pharmaceuticals | NULL | Withdrawn | 18 Years | 50 Years | All | 0 | Phase 3 | NULL |
| 151 | EUCTR2012-002714-40-GB (EUCTR) | 29/05/2014 | 28/02/2014 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1265 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 152 | EUCTR2013-003126-83-GR (EUCTR) | 27/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 153 | EUCTR2013-002351-15-ES (EUCTR) | 26/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with 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: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;Portugal;Belarus;United States;United Arab Emirates;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Peru;Denmark;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 154 | EUCTR2013-003126-83-ES (EUCTR) | 26/05/2014 | 05/03/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;Belarus;United States;United Arab Emirates;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 155 | EUCTR2013-003752-21-DE (EUCTR) | 22/05/2014 | 20/12/2013 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom | ||
| 156 | EUCTR2013-003126-83-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;Mexico;Czech Republic;Hungary;United Kingdom;Turkey;Finland;Netherlands;South Africa;Peru;Denmark;France;Italy;Colombia;Russian Federation;Chile;Israel;Ukraine;Spain;Greece;Slovakia;Serbia;Belarus;United Arab Emirates;United States | ||
| 157 | EUCTR2013-002351-15-BG (EUCTR) | 21/05/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Interferon-ß-1a Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 158 | EUCTR2013-002351-15-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden;Belgium;Brazil;Poland;Argentina;Canada;Mexico;Czech Republic;Hungary;Egypt;United Kingdom;Austria;Lithuania;Turkey;Finland;Bosnia and Herzegovina;Tunisia;Latvia;Peru;Denmark;Jordan;France;Italy;Colombia;Russian Federation | ||
| 159 | EUCTR2013-003752-21-GB (EUCTR) | 19/05/2014 | 15/10/2013 | A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;France;Taiwan;Hungary;Spain;Poland;Germany;Japan;Italy;United Kingdom | ||
| 160 | EUCTR2013-002351-15-PT (EUCTR) | 09/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Portugal;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 161 | JPRN-JapicCTI-142447 | 01/5/2014 | 19/02/2014 | Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Intervention name : BAF312 INN of the intervention : Siponimod Dosage And administration of the intervention : BAF312 will be provided in a dose titration from 0.25 mg to a 2 mg dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching Placebo administered orally. | Novartis Pharma K.K. | NULL | complete | 18 | 60 | BOTH | 1530 | Phase 3 | NULL |
| 162 | NCT02046629 (ClinicalTrials.gov) | May 2014 | 23/1/2014 | A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers | An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects | Multiple Sclerosis | Drug: Teriflunomide HMR1726;Drug: cholestyramine | Sanofi | NULL | Completed | 18 Years | 45 Years | Both | 12 | Phase 1 | China |
| 163 | EUCTR2013-002283-25-PL (EUCTR) | 18/04/2014 | 21/01/2014 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 164 | EUCTR2013-003126-83-BG (EUCTR) | 16/04/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Interferon-ß-1a Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 165 | EUCTR2013-002283-25-GB (EUCTR) | 18/03/2014 | 09/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 166 | EUCTR2013-002283-25-GR (EUCTR) | 18/03/2014 | 01/11/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 167 | EUCTR2013-002351-15-EE (EUCTR) | 13/03/2014 | 18/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 168 | EUCTR2013-002351-15-AT (EUCTR) | 13/03/2014 | 28/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 169 | EUCTR2013-002351-15-LV (EUCTR) | 03/03/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden;Turkey;Finland;Bosnia and Herzegovina;Tunisia;Latvia;Peru;Denmark;Jordan;France;Italy;Colombia;Russian Federation;Chile;Lebanon;Ukraine;Spain;Slovakia;Morocco;Estonia;Serbia;Belarus;Portugal;United Arab Emirates;United States | ||
| 170 | EUCTR2013-002283-25-BG (EUCTR) | 07/02/2014 | 04/12/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 171 | EUCTR2013-002283-25-ES (EUCTR) | 31/01/2014 | 06/11/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: -- Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 172 | EUCTR2013-002082-19-NL (EUCTR) | 09/01/2014 | 17/10/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 173 | JPRN-UMIN000012705 | 2014/01/07 | 07/01/2014 | The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years. | Department of Immunology, National Institute of Neuroscience, NCNP | NULL | Recruiting | 20years-old | 65years-old | Male and Female | 10 | Not applicable | Japan | |
| 174 | EUCTR2013-002082-19-ES (EUCTR) | 02/01/2014 | 31/10/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon beta-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon beta-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 175 | NCT01975298 (ClinicalTrials.gov) | January 2014 | 28/10/2013 | A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS). | Relapsing Remitting Multiple Sclerosis | Drug: Laquinimod;Drug: Avonex® | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Withdrawn | 18 Years | 55 Years | All | 0 | Phase 3 | Belgium;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom |
| 176 | EUCTR2013-002283-25-HR (EUCTR) | 27/12/2013 | 02/09/2014 | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Male and female patients between the ages of 18 and 60 years with a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: Plovamer acetate Other descriptive name: Plovamer acetate | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 177 | EUCTR2013-002283-25-CZ (EUCTR) | 18/12/2013 | 26/09/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 178 | EUCTR2013-002283-25-FI (EUCTR) | 09/12/2013 | 25/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 179 | EUCTR2013-002082-19-FI (EUCTR) | 04/12/2013 | 15/10/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 180 | EUCTR2013-002082-19-DK (EUCTR) | 03/12/2013 | 03/12/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 181 | NCT02047734 (ClinicalTrials.gov) | December 3, 2013 | 26/1/2014 | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study) | A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients | Relapsing Multiple Sclerosis | Drug: Ozanimod 0.5 mg;Drug: Ozanimod 1 mg;Drug: Ozanimod placebo;Drug: Interferon ß-1a;Drug: IFN ß-1a placebo | Celgene | NULL | Completed | 18 Years | 55 Years | All | 1320 | Phase 3 | United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Georgia;Greece;Hungary;Italy;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom |
| 182 | JPRN-jRCTs031180346 | 02/12/2013 | 18/03/2019 | Treatment with an anti-interleukin-6 receptor antibody for multiple sclerosis | The efficacy and safety of an anti-interluekin-6 receptor antibody in multiple sclerosis | multiple sclerosis;D009103 | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight. | Yamamura Takashi | NULL | Complete | >= 20age old | <= 65age old | Both | 6 | N/A | Japan |
| 183 | EUCTR2013-002283-25-HU (EUCTR) | 25/11/2013 | 08/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria | ||
| 184 | EUCTR2013-002082-19-BE (EUCTR) | 25/11/2013 | 13/09/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | Relapsing remitting multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 185 | EUCTR2013-002082-19-SE (EUCTR) | 21/11/2013 | 13/09/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | Relapsing remitting multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 186 | EUCTR2012-005086-12-BG (EUCTR) | 14/11/2013 | 19/08/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing 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: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 187 | EUCTR2013-002082-19-GB (EUCTR) | 13/11/2013 | 06/11/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly. | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Belgium;Denmark;Netherlands;Switzerland;United Kingdom;Sweden | ||
| 188 | EUCTR2012-005086-12-DE (EUCTR) | 12/11/2013 | 01/07/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 189 | EUCTR2010-021219-17-PL (EUCTR) | 07/11/2013 | 16/07/2013 | A 96 weeks study to compare efficacy and safety of masitinib to placebo in the treatment of patients with primary progressiveor relapse free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: masitinib INN or Proposed INN: masitinb mesylate Other descriptive name: masitinib | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;Czech Republic;Slovakia;Greece;Spain;Poland;Romania;Germany | ||
| 190 | EUCTR2013-002283-25-IT (EUCTR) | 29/10/2013 | 08/10/2013 | A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Product Name: Plovamer acetate Product Code: MSC2491529A INN or Proposed INN: ND Other descriptive name: Plovamer acetate Trade Name: Copaxone INN or Proposed INN: Glatiramer acetate Other descriptive name: GLATIRAMER ACETATE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2 | United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa | ||
| 191 | NCT01986998 (ClinicalTrials.gov) | October 2013 | 11/1/2013 | Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse | Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse. | Multiple Sclerosis | Drug: Methylprednisolone 1250 mg/24h x3 days;Drug: Oral Methylprednisolone 625 mg/24h x3 days | Germans Trias i Pujol Hospital | NULL | Completed | 18 Years | 59 Years | Both | 49 | Phase 4 | Spain |
| 192 | NCT01963611 (ClinicalTrials.gov) | October 2013 | 11/10/2013 | Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1) | A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Plovamer acetate 0.5 milligram (mg);Drug: Copaxone 20 mg;Drug: Plovamer acetate 3 mg;Drug: Plovamer acetate 10 mg;Drug: Plovamer acetate 20 mg | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 255 | Phase 2 | United States;Bulgaria;Croatia;Czech Republic;Finland;Greece;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Turkey;Ukraine;United Kingdom;Germany |
| 193 | EUCTR2012-000835-18-CZ (EUCTR) | 27/09/2013 | 17/06/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 194 | EUCTR2012-003647-30-AT (EUCTR) | 27/08/2013 | 07/02/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 195 | EUCTR2012-002714-40-ES (EUCTR) | 02/08/2013 | 09/04/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 196 | EUCTR2012-005086-12-HU (EUCTR) | 31/07/2013 | 18/06/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 197 | EUCTR2012-004807-10-DE (EUCTR) | 17/07/2013 | 26/10/2012 | Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis | Relapse Escalation treatment trial in Optic Neuritis (RESCON):Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis | MS patients who suffer from severe Optic Neuritis without satisfying improvement after treatment with steroids (3-5 days with 1 g daily at least 7 days prior to randomization) and with persisting visual acuity < 0.7, duration of symptoms should be = 4 weeks MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Urbason® solubile forte 1000 mg Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE | University Medical Center Hamburg Eppendorf | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Germany | ||
| 198 | EUCTR2012-002714-40-GR (EUCTR) | 10/07/2013 | 17/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 16.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden | ||
| 199 | EUCTR2012-003647-30-CZ (EUCTR) | 08/07/2013 | 28/11/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 200 | EUCTR2012-005086-12-AT (EUCTR) | 05/07/2013 | 08/05/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 201 | EUCTR2012-002714-40-HU (EUCTR) | 10/06/2013 | 02/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 202 | NCT01874145 (ClinicalTrials.gov) | June 2013 | 6/6/2013 | Safety and Tolerability of Glatiramer Acetate | An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: GA 20 mg/mL;Drug: GA 40 mg/mL | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | N/A | All | 209 | Phase 3 | United States |
| 203 | EUCTR2012-003056-36-IE (EUCTR) | 31/05/2013 | 06/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 204 | EUCTR2012-003647-30-IT (EUCTR) | 24/05/2013 | 11/01/2013 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - Concerto | Relapsing remitting multiple sclerosis (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: Laquinimod capsules 0.6 mg Product Code: TV-5600 Other descriptive name: Laquinimod Sodium (USAN) | TEVA PHARMACEUTICALS INDUSTRIES LTD | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany | ||
| 205 | EUCTR2012-002714-40-BG (EUCTR) | 17/05/2013 | 08/05/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;South Africa;Moldova, Republic of;Bosnia and Herzegovina | ||
| 206 | EUCTR2012-002714-40-IT (EUCTR) | 09/05/2013 | 08/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1280 | Phase 2;Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Belgium;Croatia;Georgia;Bulgaria | ||
| 207 | EUCTR2012-002714-40-BE (EUCTR) | 29/04/2013 | 14/03/2013 | A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | A PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance | RELAPSING MULTIPLE SCLEROSIS MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5 mg RPC1063 INN or Proposed INN: Ozanimod Product Name: 1 mg RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1578 | Phase 2;Phase 3 | Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Sweden;Bosnia and Herzegovina | ||
| 208 | EUCTR2012-000835-18-HU (EUCTR) | 15/04/2013 | 28/02/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 209 | EUCTR2012-003647-30-PL (EUCTR) | 11/04/2013 | 12/02/2013 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;Estonia | ||
| 210 | EUCTR2012-003056-36-GB (EUCTR) | 08/04/2013 | 02/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 211 | EUCTR2012-003056-36-BG (EUCTR) | 20/03/2013 | 06/02/2013 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 212 | EUCTR2012-000835-18-NL (EUCTR) | 19/03/2013 | 03/01/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 213 | EUCTR2010-021219-17-GR (EUCTR) | 19/03/2013 | 30/01/2013 | A clinical study to compare the efficacy and safety of masitinib 4.5 mg/kg/day vs. placebo in the treatment of patients with multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinb mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovakia;Greece;Poland;Spain;Turkey;Bulgaria;Germany | ||
| 214 | EUCTR2012-003056-36-PL (EUCTR) | 18/03/2013 | 20/12/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 215 | EUCTR2012-000835-18-GB (EUCTR) | 18/03/2013 | 09/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 216 | NCT01808482 (ClinicalTrials.gov) | March 13, 2013 | 7/3/2013 | A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | A First Time in Human Study Exploring Preliminary Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Part A: 100 mg/mL GSK2618960;Drug: Part A: matching placebo;Drug: Part B: Dose of GSK2618960 decided from Part A;Drug: Part B: matching placebo;Drug: Part C: Dose of GSK2618960 decided from Part A and B | GlaxoSmithKline | NULL | Terminated | 18 Years | 55 Years | Male | 16 | Phase 1 | United Kingdom |
| 217 | EUCTR2012-000835-18-DE (EUCTR) | 26/02/2013 | 06/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 218 | NCT01707992 (ClinicalTrials.gov) | February 20, 2013 | 28/9/2012 | The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Laquinimod;Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 55 Years | All | 2199 | Phase 3 | United States;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Montenegro;North Macedonia;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom;Czech Republic;Kazakhstan;Macedonia, The Former Yugoslav Republic of;Mexico;Portugal |
| 219 | EUCTR2012-000835-18-ES (EUCTR) | 23/01/2013 | 29/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 15.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: GYLENIA 0,5 mg Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Farmaceutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 220 | EUCTR2012-003056-36-BE (EUCTR) | 21/01/2013 | 19/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 221 | EUCTR2012-000835-18-BE (EUCTR) | 18/01/2013 | 19/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 222 | EUCTR2012-003647-30-BE (EUCTR) | 18/01/2013 | 08/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany | ||
| 223 | EUCTR2012-003056-36-GR (EUCTR) | 15/01/2013 | 23/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 224 | EUCTR2012-000835-18-IT (EUCTR) | 12/01/2013 | 19/12/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Sweden | |||
| 225 | EUCTR2012-003647-30-HU (EUCTR) | 04/01/2013 | 25/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 226 | EUCTR2012-003647-30-ES (EUCTR) | 04/01/2013 | 29/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany | ||
| 227 | EUCTR2012-003647-30-EE (EUCTR) | 03/01/2013 | 19/11/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 228 | NCT01779934 (ClinicalTrials.gov) | January 2013 | 26/10/2012 | OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: FTY720 | Novartis Pharmaceuticals | NULL | Completed | 28 Years | N/A | Both | 579 | Phase 3 | United States;Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 229 | EUCTR2012-003056-36-LT (EUCTR) | 21/12/2012 | 29/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 230 | EUCTR2012-003647-30-GB (EUCTR) | 20/12/2012 | 23/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) consisting of two parts: First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 231 | EUCTR2012-000835-18-FR (EUCTR) | 20/12/2012 | 19/06/2013 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 232 | EUCTR2012-003056-36-LV (EUCTR) | 18/12/2012 | 18/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 233 | EUCTR2012-003056-36-DE (EUCTR) | 14/12/2012 | 11/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 234 | EUCTR2012-003647-30-LV (EUCTR) | 13/12/2012 | 25/10/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 235 | EUCTR2012-003056-36-EE (EUCTR) | 13/12/2012 | 09/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 236 | EUCTR2012-003056-36-SE (EUCTR) | 12/12/2012 | 08/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 237 | EUCTR2012-003056-36-PT (EUCTR) | 11/12/2012 | 11/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 238 | EUCTR2012-003647-30-GR (EUCTR) | 11/12/2012 | 14/11/2012 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Albania;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany | ||
| 239 | EUCTR2012-003056-36-SK (EUCTR) | 10/12/2012 | 13/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 240 | EUCTR2012-003056-36-ES (EUCTR) | 04/12/2012 | 02/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Farmacéutica S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Australia;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Sweden | |||
| 241 | EUCTR2012-003647-30-SK (EUCTR) | 04/12/2012 | 20/02/2014 | A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug). | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO | Relapsing remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: LAQUINIMOD Other descriptive name: Laquinimod Sodium (USAN) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2100 | Phase 3 | Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 242 | EUCTR2012-000835-18-FI (EUCTR) | 28/11/2012 | 08/11/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 243 | EUCTR2012-003056-36-AT (EUCTR) | 28/11/2012 | 08/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Argentina;Canada;Czech Republic;Hungary;United Kingdom;Austria;Lithuania;Turkey;China;Netherlands;Latvia;Australia;France;Italy;Switzerland;Russian Federation;Israel;Ireland;Spain;Greece;Slovakia;Estonia;Portugal;United States | ||
| 244 | EUCTR2012-003056-36-CZ (EUCTR) | 08/11/2012 | 12/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 245 | EUCTR2012-001965-34-ES (EUCTR) | 07/11/2012 | 09/08/2012 | Study to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse. | Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse. | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Urbason 40 mg Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE | Servicio de Neurología, HU. Germans Trias i Pujol | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Spain | |||
| 246 | EUCTR2012-000835-18-SE (EUCTR) | 07/11/2012 | 01/10/2012 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 16.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 700 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 247 | EUCTR2012-003056-36-HU (EUCTR) | 31/10/2012 | 03/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 248 | EUCTR2012-003418-15-AT (EUCTR) | 23/10/2012 | 09/11/2012 | Methylphenidate modified release as treatment of MS-associated fatigue. | Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial. | Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ritalin LA 20mg capsules Product Name: Methylphenidate modified release 20 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 30mg capsules Product Name: Methylphenidate modified release 30 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 40mg capsules Product Name: Methylphenidate modified release 40 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE | Medizinische Universität Wien | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | ||||
| 249 | EUCTR2012-000368-90-NL (EUCTR) | 02/10/2012 | 06/08/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Canada;Belgium;Netherlands;United Kingdom;Italy;Sweden | |||
| 250 | NCT01667484 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | Adderall XR and Processing Speed in Multiple Sclerosis (MS) | Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients? | Impaired Processing Speed;Cognitive Impairment;Multiple Sclerosis | Drug: Adderall XR 5mg;Drug: Adderall XR 10 mg;Drug: Placebo | London Health Sciences Centre | NULL | Completed | 18 Years | 59 Years | Both | 70 | Phase 2/Phase 3 | Canada |
| 251 | NCT01633112 (ClinicalTrials.gov) | August 9, 2012 | 29/6/2012 | MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone | A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis (RRMS) | Drug: fingolimod;Drug: glatiramer acetate | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 1064 | Phase 3 | United States;Argentina;Brazil;Canada;Chile;Mexico;Puerto Rico |
| 252 | EUCTR2012-000368-90-BE (EUCTR) | 08/08/2012 | 11/06/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Canada;Belgium;Netherlands;Italy;United Kingdom;Sweden | ||
| 253 | NCT01597297 (ClinicalTrials.gov) | August 2012 | 10/5/2012 | Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: BIIB041 (PR Fampridine);Other: Placebo | Biogen | NULL | Completed | 18 Years | 70 Years | All | 132 | Phase 2 | Belgium;Canada;Italy;Netherlands;Sweden;United Kingdom |
| 254 | EUCTR2012-000368-90-IT (EUCTR) | 30/07/2012 | 12/09/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra INN or Proposed INN: FAMPRIDINE | BIOGEN IDEC RESEARCH LTD | NULL | Not Recruiting | Female: yes Male: yes | 120 | Canada;Belgium;Netherlands;United Kingdom;Switzerland;Italy | |||
| 255 | EUCTR2012-000368-90-GB (EUCTR) | 27/06/2012 | 10/07/2012 | Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE) | Multiple Sclerosis MedDRA version: 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] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Canada;Belgium;Netherlands;Italy;United Kingdom;Sweden | |||
| 256 | EUCTR2011-005550-57-GR (EUCTR) | 05/06/2012 | 09/05/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Serbia;Ukraine;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of | |||
| 257 | JPRN-jRCTs031180152 | 04/06/2012 | 25/02/2019 | Tocilizumab in patients with neuromyelitis optica | The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter study - Tocilizumab in patients with neuromyelitis optica | Neuromyelitis optica;D009471 | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months. | Yamamura Takashi | NULL | Complete | >= 20age old | <= 65age old | Both | 20 | N/A | Japan |
| 258 | EUCTR2011-005550-57-EE (EUCTR) | 21/05/2012 | 14/02/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina | |||
| 259 | EUCTR2011-005550-57-LV (EUCTR) | 15/05/2012 | 09/02/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina | |||
| 260 | EUCTR2011-005550-57-BG (EUCTR) | 14/05/2012 | 07/03/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Germany;Moldova, Republic of;Bosnia and Herzegovina;Latvia;Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Bulgaria;Albania | |||
| 261 | JPRN-UMIN000007866 | 2012/05/01 | 01/05/2012 | The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study | neuromyelitis optica | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years. | Department of Immunology, National Institute of Neuroscience, NCNP | Department of Neurology, Kinki University Faculty of Mediceine | Complete: follow-up continuing | 20years-old | 65years-old | Male and Female | 15 | Not applicable | Japan | |
| 262 | NCT01585766 (ClinicalTrials.gov) | April 24, 2012 | 9/4/2012 | Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis | A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing Forms | Drug: MEDI-551 30 MG-IV;Drug: MEDI-551 60 MG-SC;Drug: PLACEBO-IV-SC;Drug: MEDI-551 100 MG-IV;Drug: MEDI-551 300 MG-SC;Drug: MEDI-551 600 MG-IV | MedImmune LLC | NULL | Completed | 18 Years | 65 Years | All | 56 | Phase 1 | United States;Poland;Spain;Ukraine;Czech Republic;United Kingdom |
| 263 | EUCTR2011-005550-57-PL (EUCTR) | 04/04/2012 | 09/03/2012 | A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug). | A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study | Relapsing-remitting Multiple sclerosis (RRMS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: 20mg/0.5ml glatiramer acetate Product Code: 20mg/0.5ml GA INN or Proposed INN: glatiramer acetate Other descriptive name: glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Hungary;Germany;Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Czech Republic;Ukraine;Serbia;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of | |||
| 264 | EUCTR2010-020515-37-NO (EUCTR) | 22/03/2012 | 15/02/2011 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 265 | NCT01578785 (ClinicalTrials.gov) | March 2012 | 13/3/2012 | An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Placebo | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 55 Years | All | 178 | Phase 3 | United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Greece;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Montenegro;Poland;Romania;Russian Federation;Serbia;Ukraine;Lithuania |
| 266 | EUCTR2011-006043-30-NL (EUCTR) | 27/02/2012 | 16/02/2012 | Study to evaluate the effect of oral BAF312 on a monophasic oral contraceptive in healthy female volunteers | An open-label, multiple-dose, two-treatment period study to evaluate the effect of oral BAF312 on the pharmacokinetices and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteers - | healthy volunteers (Multiple sclerosis is the intended indication for BAF312) ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BAF312 0,25 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Product Name: BAF312 4 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Trade Name: Microgynon Product Name: Microgynon INN or Proposed INN: ETHINYLESTRADIOL Other descriptive name: LEVONORGESTREL | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: no | 24 | Netherlands | |||
| 267 | EUCTR2011-003507-38-IT (EUCTR) | 22/02/2012 | 02/03/2012 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Dailyon Quality of Life as Reported by Subjects with 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] | Trade Name: Fampyra INN or Proposed INN: FAMPRIDINE Other descriptive name: NA | BIOGEN IDEC RESEARCH LTD | NULL | Not Recruiting | Female: yes Male: yes | 800 | Portugal;Denmark;Australia;Netherlands;United Kingdom;Italy | |||
| 268 | EUCTR2011-003507-38-PT (EUCTR) | 03/02/2012 | 28/11/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with 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] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 800 | France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 269 | EUCTR2010-021219-17-SK (EUCTR) | 01/02/2012 | 06/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Tunisia;Germany;Bosnia and Herzegovina | ||
| 270 | NCT01480076 (ClinicalTrials.gov) | February 2012 | 23/11/2011 | Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine | Biogen | NULL | Completed | 18 Years | 75 Years | All | 901 | Phase 4 | Australia;Belgium;Denmark;France;Germany;Italy;Netherlands;Portugal;United Kingdom;United States |
| 271 | NCT01497262 (ClinicalTrials.gov) | February 2012 | 5/12/2011 | Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 162 | Phase 3 | Argentina;Brazil;Colombia;Jordan;Malaysia;Mexico;Panama;Peru;Costa Rica |
| 272 | EUCTR2011-003507-38-BE (EUCTR) | 23/01/2012 | 04/11/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 273 | EUCTR2011-003507-38-GB (EUCTR) | 06/01/2012 | 20/10/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with 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] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 4 | United Kingdom;Sweden;France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy | ||
| 274 | EUCTR2011-003507-38-NL (EUCTR) | 05/01/2012 | 07/11/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with 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] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 800 | France;Portugal;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 275 | EUCTR2011-003507-38-DK (EUCTR) | 05/01/2012 | 05/12/2011 | Long-Term Prolonged-Release Fampridine Treatment and Quality of Life | An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with 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] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 INN or Proposed INN: FAMPRIDINE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 800 | France;Portugal;Belgium;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 276 | NCT01534182 (ClinicalTrials.gov) | January 2012 | 8/2/2012 | Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Interferon beta - 1a (IFN);Drug: Glatiramer acetate (GA) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 298 | Phase 4 | Russian Federation |
| 277 | EUCTR2010-021219-17-DE (EUCTR) | 31/10/2011 | 05/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate INN or Proposed INN: masitinb mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate INN or Proposed INN: masitinb mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Germany;Tunisia;Bosnia and Herzegovina | ||
| 278 | EUCTR2010-021219-17-ES (EUCTR) | 12/09/2011 | 01/07/2011 | Evaluación de masitinib en esclerosis múltiple | Estudio prospectivo Fase III, multicéntrico, randomizado, doble ciego, de dos grupos paralelos, controlado con placebo y de 96 semanas de duración, para comparar la eficacia y seguridad de masitinib a la dosis de 6 mg/kg/día con placebo en el tratamiento de pacientes con esclerosis múltiple primaria progresiva o esclerosis múltiple secundaria progresiva sin recidiva | Pacientes con esclerosis múltiple primaria progresiva o secundaria progresiva sin recidiva MedDRA version: 14.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Slovakia;Greece;Poland;Spain;Romania;Bulgaria;Germany | ||
| 279 | NCT01433497 (ClinicalTrials.gov) | August 2011 | 12/9/2011 | Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis | A 96 Week, Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled, 2 Parallel-groups, Phase 3 Study to Compare Efficacy and Safety of Masitinib 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Secondary Progressive;Multiple Sclerosis, Primary Progressive;Multiple Sclerosis, Relapse Free | Drug: Masitinib;Drug: Placebo | AB Science | NULL | Completed | 18 Years | 75 Years | All | 656 | Phase 3 | Bulgaria;France;Germany;Greece;Poland;Romania;Spain;United States |
| 280 | JPRN-UMIN000005889 | 2011/07/01 | 08/07/2011 | The safety and efficacy of tocilizumab in patients with neuromyelitis optica | neuromyelitis optica | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months. | Department of Immunology, National Institute of Neuroscience, NCNP | NULL | Complete: follow-up complete | 20years-old | 65years-old | Male and Female | 3 | Not applicable | Japan | |
| 281 | NCT01417312 (ClinicalTrials.gov) | July 2011 | 15/8/2011 | Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients | Multiple Sclerosis, Relapsing-Remitting | Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG);Dietary Supplement: Placebo | Charite University, Berlin, Germany | NULL | Completed | 20 Years | 60 Years | All | 20 | N/A | Germany | |
| 282 | NCT01359566 (ClinicalTrials.gov) | May 2011 | 22/5/2011 | Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis | A Randomized, Double Blind, Placebo-Controlled Efficacy and Safety Study of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis | Multiple Sclerosis | Drug: Arbaclofen placarbil 15 mg BID;Drug: Placebo;Drug: Arbaclofen placarbil 30 mg BID;Drug: Arbaclofen placarbil 45 mg BID | XenoPort, Inc. | NULL | Completed | 18 Years | 70 Years | All | 228 | Phase 3 | United States |
| 283 | NCT01317004 (ClinicalTrials.gov) | May 2011 | 15/3/2011 | Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Standard MS DMT | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 61 | Phase 4 | Italy |
| 284 | EUCTR2010-024017-31-IT (EUCTR) | 15/03/2011 | 08/02/2011 | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: FINGOLIMOD Product Code: FTY720D Trade Name: EXTAVIA INN or Proposed INN: Interferon beta-1b Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 285 | NCT01328379 (ClinicalTrials.gov) | March 2011 | 29/3/2011 | Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis | Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Doses of Oral Dalfampridine Extended Release Tablets (5 mg and 10 mg Twice Daily) in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Dalfampridine-ER 5mg;Drug: Dalfampridine-ER 10mg;Other: Placebo | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 430 | Phase 3 | United States |
| 286 | EUCTR2010-020515-37-DK (EUCTR) | 14/02/2011 | 03/01/2011 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. - | Relapsing multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Denmark;Estonia;Spain;Greece | ||||
| 287 | NCT01281657 (ClinicalTrials.gov) | February 2011 | 19/1/2011 | Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program | A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program | Multiple Sclerosis | Drug: fingolimod | Novartis | NULL | Completed | 18 Years | N/A | Both | 64 | N/A | United States;Canada |
| 288 | NCT01310166 (ClinicalTrials.gov) | February 2011 | 24/2/2011 | Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | A 6-month Multicenter, Single-arm, Open-label Study to Investigate Changes in Biomarkers After Initiation of Treatment With 0.5 mg Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | Both | 447 | Phase 4 | Germany |
| 289 | EUCTR2010-022066-28-DE (EUCTR) | 18/01/2011 | 29/09/2010 | A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosis | A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosis | relapsing remitting 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] | Trade Name: Gilenya Product Name: Gilenya Other descriptive name: Fingolimod | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 3 | Germany | ||
| 290 | EUCTR2010-020515-37-IE (EUCTR) | 04/01/2011 | 13/10/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 291 | EUCTR2010-020515-37-CZ (EUCTR) | 03/01/2011 | 27/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Romania;Norway;Germany;Sweden;Poland;Belgium;Brazil | ||
| 292 | EUCTR2010-020515-37-BE (EUCTR) | 17/12/2010 | 28/10/2010 | Long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Greece;Spain;Costa Rica;Ireland;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;Sweden | ||
| 293 | EUCTR2009-017939-18-GB (EUCTR) | 15/12/2010 | 27/08/2010 | A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS | A Phase 4 randomised, double-blind, placebo controlled, crossover trial Nitrofurantoin Macrocrystals 100 mg twice daily for six weeks in the treatment of overactive bladder symptoms associated with a negative mid stream urine culture and pyuria in patients with and without Multiple Sclerosis. - Recurrent urine infection in OAB patients with and without MS | Chronic urinary tract infection. MedDRA version: 16.1;Level: LLT;Classification code 10059617;Term: Overactive bladder;System Organ Class: 100000004857 | Trade Name: Nitrofurantoin Product Name: Nitrofurantoin Product Code: PL 12762/0049 INN or Proposed INN: Nitrofurantoin Other descriptive name: Nitrofurantoin | University College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 294 | EUCTR2009-011470-15-NL (EUCTR) | 03/12/2010 | 03/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 295 | EUCTR2010-020515-37-NL (EUCTR) | 01/12/2010 | 12/10/2010 | long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;Portugal;Comoros;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria | ||
| 296 | EUCTR2007-002627-32-DK (EUCTR) | 29/11/2010 | 20/10/2010 | A study to evaluate how safe and effective 0.5 mg fingolimod is in delaying disability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | |||
| 297 | EUCTR2009-012989-30-AT (EUCTR) | 25/11/2010 | 14/12/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 298 | EUCTR2010-020515-37-FR (EUCTR) | 19/11/2010 | 06/09/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 299 | EUCTR2010-020515-37-IT (EUCTR) | 25/10/2010 | 14/09/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis - ND | MS (MULTIPLE SCLEROSIS) MedDRA version: 9.1;Level: LLT;Classification code 10048393 | Product Name: fingolimod Product Code: FTY720D | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 300 | EUCTR2010-020515-37-AT (EUCTR) | 21/10/2010 | 15/09/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 301 | EUCTR2010-020515-37-ES (EUCTR) | 20/10/2010 | 02/08/2010 | Estudio multicéntrico, abierto, de un único grupo que evalúa la seguridad y tolerabilidad a largo plazo de fingolimod 0,5 mg (FTY720) administrado por vía oral una vez al día en pacientes con formas recidivantes de esclerosis múltiple | Estudio multicéntrico, abierto, de un único grupo que evalúa la seguridad y tolerabilidad a largo plazo de fingolimod 0,5 mg (FTY720) administrado por vía oral una vez al día en pacientes con formas recidivantes de esclerosis múltiple | Esclerosis Múltiple Remitente Recurrente MedDRA version: 12.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 302 | EUCTR2010-020515-37-SK (EUCTR) | 18/10/2010 | 03/08/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 303 | EUCTR2009-015815-42-LT (EUCTR) | 11/10/2010 | 09/08/2010 | An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 304 | EUCTR2010-020515-37-PT (EUCTR) | 11/10/2010 | 23/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 305 | EUCTR2010-020515-37-EE (EUCTR) | 08/10/2010 | 09/09/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis (LONGTERMS). | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Ireland;Portugal;United States;Estonia;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 306 | EUCTR2010-020515-37-GR (EUCTR) | 05/10/2010 | 04/10/2010 | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 307 | NCT01166178 (ClinicalTrials.gov) | October 2010 | 19/7/2010 | Zoledronic Acid in MS-patients With Osteoporosis | A 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment Phase | Osteoporosis;Multiple Sclerosis | Drug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combination | Novartis | NULL | Terminated | 18 Years | 75 Years | All | 29 | Phase 3 | Germany |
| 308 | EUCTR2010-020515-37-HU (EUCTR) | 30/09/2010 | 11/08/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 309 | EUCTR2010-020515-37-GB (EUCTR) | 27/09/2010 | 17/08/2010 | Long-term safety and tolerability of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 310 | EUCTR2010-020515-37-SE (EUCTR) | 27/09/2010 | 24/08/2010 | Long-term safety, tolerability and efficacy study of 0.5 mg fingolimodonce daily in patients with multiple sclerosis. | A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis. | Multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 311 | EUCTR2009-010788-18-ES (EUCTR) | 27/09/2010 | 08/01/2010 | Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab. | Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab. | Esclerosis Multiple de Recaida-Remision/Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MABCAMPATH 10 mg/ml concentrado para solución para perfusión INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 312 | EUCTR2009-011470-15-PL (EUCTR) | 14/09/2010 | 25/05/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 313 | NCT01201356 (ClinicalTrials.gov) | September 13, 2010 | 10/9/2010 | Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis | A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 4125 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;Egypt;Estonia;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Jordan;Korea, Republic of;Malaysia;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom;Costa Rica;Czech Republic |
| 314 | EUCTR2010-020515-37-DE (EUCTR) | 13/09/2010 | 09/07/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Trade Name: Gilenya 0,5 mg Hartkapseln Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 315 | EUCTR2009-011470-15-DE (EUCTR) | 20/08/2010 | 08/04/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: | ACTELION Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 316 | EUCTR2009-011470-15-BG (EUCTR) | 12/08/2010 | 30/04/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | United States;Serbia;Czechia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 317 | EUCTR2010-020515-37-FI (EUCTR) | 06/08/2010 | 24/06/2010 | Long-term safety and tolerability study of 0.5 mg fingolimod once daily in patients with relapsing forms of multiple sclerosis | A single arm, open-label, multicenter study evaluating the long-term, safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis. | multiple sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Jordan;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;Sweden | ||
| 318 | EUCTR2009-011470-15-AT (EUCTR) | 03/08/2010 | 28/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: ponesimod Product Code: ACT-128800 INN or Proposed INN: ponesimod Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 319 | NCT01216072 (ClinicalTrials.gov) | August 2010 | 7/9/2010 | A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis | A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC) | Relapsing Forms of Multiple Sclerosis | Drug: Fingolimod;Drug: Standard MS DMTs | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 1053 | Phase 4 | United States;Canada;Puerto Rico |
| 320 | EUCTR2009-018084-27-GB (EUCTR) | 29/07/2010 | 08/06/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Poland;Croatia;Romania;South Africa;Georgia;Bulgaria;Germany;United States;Estonia;Ukraine;Lithuania;Israel | ||
| 321 | EUCTR2009-011888-37-DE (EUCTR) | 23/07/2010 | 26/03/2010 | A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT | A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT | osteoporosis in patients with multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10049088;Term: Osteopenia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10031282;Term: Osteoporosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Aclasta 5 mg Infusionslösung Product Name: Aclasta Product Code: ZOL446H Other descriptive name: ZOLEDRONIC ACID MONOHYDRATE | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 322 | EUCTR2009-018084-27-BG (EUCTR) | 19/07/2010 | 30/04/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;South Africa;Georgia;Germany | ||
| 323 | EUCTR2009-015815-42-CZ (EUCTR) | 12/07/2010 | 12/05/2010 | An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 324 | EUCTR2009-015815-42-PL (EUCTR) | 08/07/2010 | 17/05/2010 | An extended clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-302 (BRAVO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 325 | EUCTR2009-011470-15-HU (EUCTR) | 08/07/2010 | 01/06/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden | ||
| 326 | EUCTR2009-015815-42-SK (EUCTR) | 06/07/2010 | 17/05/2010 | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1245 | Phase 3 | Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 327 | NCT01167426 (ClinicalTrials.gov) | July 2010 | 20/7/2010 | Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients | An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method. | Multiple Sclerosis | Drug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mL | Teva Neuroscience, Inc. | NULL | Completed | 18 Years | N/A | All | 148 | Phase 3 | United States |
| 328 | NCT01067521 (ClinicalTrials.gov) | June 22, 2010 | 10/2/2010 | A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind Design | A Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind Design | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer acetate (GA);Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 55 Years | All | 1404 | Phase 3 | United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Poland;Romania;Russian Federation;South Africa;Ukraine;United Kingdom;Czech Republic;Turkey |
| 329 | EUCTR2009-011470-15-GB (EUCTR) | 22/06/2010 | 29/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Sweden;United States;Serbia;Finland;Spain;Ukraine;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands | ||
| 330 | EUCTR2009-018084-27-DE (EUCTR) | 16/06/2010 | 09/03/2010 | A clincial study to find out whether Copaxone (glatiramer acetate 40mg/1ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 331 | EUCTR2009-018084-27-CZ (EUCTR) | 01/06/2010 | 29/03/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 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: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 332 | NCT01156311 (ClinicalTrials.gov) | June 2010 | 1/7/2010 | BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis | An Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNß) or Glatiramer Acetate (GA) | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | 55 Years | All | 108 | Phase 2 | United States |
| 333 | EUCTR2009-018084-27-LT (EUCTR) | 28/05/2010 | 01/04/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 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: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 334 | NCT01047319 (ClinicalTrials.gov) | May 27, 2010 | 8/1/2010 | A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis | A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Laquinimod | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Terminated | N/A | N/A | All | 1047 | Phase 3 | United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Macedonia, The Former Yugoslav Republic of;Puerto Rico |
| 335 | EUCTR2009-015556-15-ES (EUCTR) | 24/05/2010 | 24/03/2010 | Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS | Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: TYSABRI 300 mg concentrado para solución para perfusión INN or Proposed INN: NATALIZUMAB Other descriptive name: NATALIZUMAB Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada INN or Proposed INN: GLATIRAMERO ACETATO Other descriptive name: GLATIRAMER ACETATE Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 336 | EUCTR2009-018084-27-IT (EUCTR) | 19/05/2010 | 07/06/2010 | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design - GALA | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design - GALA | Subject with Relapse-Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Product Name: 40 mg Glatiramer Acetate Product Code: 40 mg GA INN or Proposed INN: Glatiramer acetate | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Czech Republic;Estonia;Hungary;Lithuania;Bulgaria;Germany;United Kingdom;Italy | ||
| 337 | EUCTR2009-011470-15-ES (EUCTR) | 18/05/2010 | 22/03/2010 | Estudio de extensión del estudio AC-058B201, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, para evaluar la seguridad, tolerabilidad, y eficacia a largo plazo de 10, 20, y 40 mg/día de ACT-128800, un agonista oral de los receptores S1P1, en pacientes con esclerosis múltiple recurrente-remitente - | Esclerosi Múltiple Recurrente-Remitente MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 Product Name: ACT-128800 Product Code: ACT-128800 | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;Spain;Italy;Austria;Poland;Sweden | ||||
| 338 | EUCTR2009-015815-42-BG (EUCTR) | 18/05/2010 | 18/05/2010 | An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 339 | NCT01093326 (ClinicalTrials.gov) | May 12, 2010 | 24/3/2010 | Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis | Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Ponesimod 10 mg;Drug: Ponesimod 20 mg;Drug: Ponesimod 40 mg | Actelion | NULL | Active, not recruiting | 18 Years | 55 Years | All | 353 | Phase 2 | Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Austria;Bulgaria;Canada;Czechia;Finland;France;United States;Czech Republic;Italy |
| 340 | EUCTR2009-018084-27-EE (EUCTR) | 07/05/2010 | 16/03/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 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: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Croatia;Romania;Georgia;South Africa;Bulgaria;Germany | ||
| 341 | EUCTR2009-011470-15-CZ (EUCTR) | 30/04/2010 | 29/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Canada;Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 342 | EUCTR2009-011470-15-IT (EUCTR) | 29/04/2010 | 27/12/2011 | Multicenter, randomized, double-blind, parallel-group extension to study AC-058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ACT-128800, an oral S1P1 receptor agonist, in patients 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: ACT-128800 Product Code: ACT-128800 INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS Product Name: ACT-128800 Product Code: ACT-128800 INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS Product Name: ACT-128800 Product Code: ACT-128800 INN or Proposed INN: IMMUNOSUPPRESSIVE AGENTS | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;Spain;Italy;Austria;Poland;Sweden | ||||
| 343 | EUCTR2009-011470-15-SE (EUCTR) | 12/04/2010 | 04/03/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Sweden;Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany | ||
| 344 | EUCTR2007-002627-32-HU (EUCTR) | 31/03/2010 | 05/02/2010 | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | Primary progressive multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 940 | France;Czech Republic;Hungary;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 345 | EUCTR2009-012989-30-BG (EUCTR) | 31/03/2010 | 19/04/2010 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 346 | EUCTR2009-018084-27-HU (EUCTR) | 30/03/2010 | 01/03/2010 | A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug). | A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 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: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany | ||
| 347 | EUCTR2009-011470-15-FI (EUCTR) | 30/03/2010 | 09/02/2010 | An international study, which is an extension to protocol AC 058B201, with the aim to study how safe and efficacious is the long-term treatment with ponesimod in three different doses in patients with relapsing-remitting multiple sclerosis. | Multicenter, randomized, double-blind, parallel-group extension to study AC 058B201 to investigate the long-term safety, tolerability, and efficacy of 10, 20, and 40 mg/day ponesimod, an oral S1P1 receptor agonist, in patients with relapsing-remitting multiple sclerosis | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ponesimod Product Code: ACT-128800 Product Name: ponesimod Product Code: ACT-128800 Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: PONESIMOD | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 353 | Phase 2 | Serbia;United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 348 | EUCTR2008-005167-33-DE (EUCTR) | 29/03/2010 | 16/03/2010 | Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAX | Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease - GABATAX | Patients with cerebellar ataxia with coordination deficits in walking, upper and lower limb movements and oculomtoor coordination deficits are included in the trial. The cause of their atayia is either a degenerative CNS disease (36 patients) such as autosomal dominant Spinocerebellar Ataxia or sporadic ataxia with late onset or inflammatory CNS disease (Multiple Sclerosis; 36 patients). | Trade Name: Neurontin 300 mg hard capsule Product Name: gabapentine 300mg Product Code: GBP INN or Proposed INN: Gabapentin Other descriptive name: GABAPENTIN | Charité University Medicine Berlin | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 349 | EUCTR2009-015815-42-IT (EUCTR) | 15/03/2010 | 01/03/2010 | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10063399 | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: Laquinimod | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1245 | Phase 3 | Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 350 | EUCTR2009-015815-42-EE (EUCTR) | 12/03/2010 | 12/02/2010 | An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the disease | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 351 | EUCTR2009-012989-30-SE (EUCTR) | 23/02/2010 | 01/02/2010 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 352 | EUCTR2009-012989-30-FR (EUCTR) | 18/01/2010 | 22/09/2009 | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden | ||
| 353 | EUCTR2009-012989-30-LT (EUCTR) | 30/12/2009 | 02/10/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 354 | 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 |
| 355 | EUCTR2009-012989-30-GB (EUCTR) | 17/11/2009 | 13/07/2009 | A clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 356 | EUCTR2009-012989-30-CZ (EUCTR) | 16/11/2009 | 10/09/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 357 | NCT00988052 (ClinicalTrials.gov) | November 10, 2009 | 28/9/2009 | A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS | A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS | Relapsing Multiple Sclerosis | Drug: Laquinimod | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Terminated | 18 Years | 55 Years | All | 839 | Phase 3 | United States;Austria;Bulgaria;Canada;Czechia;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;Latvia |
| 358 | 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 | ||
| 359 | EUCTR2009-012989-30-ES (EUCTR) | 21/10/2009 | 05/08/2009 | Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - - | Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - - | Esclerosis Múltiple Remitente Recurrente (RRMS). MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsulas 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden | ||
| 360 | EUCTR2006-003361-14-CZ (EUCTR) | 12/10/2009 | 05/05/2009 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 361 | EUCTR2009-012989-30-IT (EUCTR) | 06/10/2009 | 11/09/2009 | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND | Relapsing - Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod INN or Proposed INN: Laquinimod | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden | ||
| 362 | EUCTR2009-012989-30-NL (EUCTR) | 02/10/2009 | 20/07/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 632 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 363 | EUCTR2006-003361-14-EE (EUCTR) | 25/09/2009 | 19/08/2009 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;Estonia;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 364 | 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 | |||
| 365 | EUCTR2006-001152-12-DE (EUCTR) | 14/09/2009 | 04/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 366 | EUCTR2009-012989-30-EE (EUCTR) | 11/09/2009 | 05/08/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 367 | EUCTR2009-012989-30-HU (EUCTR) | 09/09/2009 | 14/08/2009 | A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease. | A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 632 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 368 | EUCTR2009-013129-41-NL (EUCTR) | 20/07/2009 | 03/06/2009 | A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT | A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT | clinical isolated syndrome MedDRA version: 9.1;Level: LLT;Classification code 10028248;Term: Multiple sclerosis-like syndrome | Trade Name: Copaxone Product Name: Copaxone Other descriptive name: GLATIRAMER ACETATE | Amphia Ziekenhuis | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 369 | EUCTR2009-011234-99-DE (EUCTR) | 23/06/2009 | 21/04/2009 | A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administereddaily in subjects with relapsing remitting multiple sclerosis (RRMS) | A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administereddaily in subjects with relapsing remitting multiple sclerosis (RRMS) - MS-LAQ-101 | Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis (RRMS).This study is planned to assess the tolerability and safety of escalating doses of orallaquinimod administered daily in subjects with RRMS. MedDRA version: 15.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt Product Name: Laquinimod Capsules 0.3 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 1 | Germany | ||
| 370 | EUCTR2006-001152-12-LT (EUCTR) | 22/06/2009 | 31/03/2009 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 371 | EUCTR2007-004122-24-EE (EUCTR) | 25/05/2009 | 23/04/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720 INN or Proposed INN: fingolimod Product Name: FTY720 Product Code: FTY720 INN or Proposed INN: fingolimod | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 372 | EUCTR2007-004122-24-IE (EUCTR) | 22/05/2009 | 04/03/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod INN or Proposed INN: fingolimod | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 373 | EUCTR2007-002627-32-GB (EUCTR) | 05/05/2009 | 18/04/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - Efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 374 | EUCTR2008-001999-67-DE (EUCTR) | 23/04/2009 | 16/03/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | France;Finland;Spain;Germany | |||
| 375 | EUCTR2007-004122-24-HU (EUCTR) | 23/04/2009 | 16/02/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Sweden | |||
| 376 | EUCTR2007-004122-24-FI (EUCTR) | 08/04/2009 | 04/06/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 377 | EUCTR2008-002096-27-AT (EUCTR) | 19/03/2009 | 09/07/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis with optional extension phase - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Poland;Austria;Lithuania | |||
| 378 | EUCTR2008-001999-67-FI (EUCTR) | 19/03/2009 | 28/01/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Finland;Germany;France;Spain | |||
| 379 | EUCTR2008-001999-67-FR (EUCTR) | 16/03/2009 | 03/02/2009 | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Phase 2 | France;Finland;Spain;Germany | ||
| 380 | NCT00853762 (ClinicalTrials.gov) | March 2009 | 26/2/2009 | Atacicept in Multiple Sclerosis Extension Study, Phase II | An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension) | Relapsing Multiple Sclerosis | Drug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mg | EMD Serono | Merck KGaA | Terminated | 18 Years | 60 Years | All | 74 | Phase 2 | United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 381 | EUCTR2007-002627-32-CZ (EUCTR) | 04/02/2009 | 09/04/2008 | efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | Finland;Spain;Ireland;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;South Africa;Netherlands;Germany;Sweden | |||
| 382 | EUCTR2008-001999-67-ES (EUCTR) | 30/01/2009 | 17/11/2008 | Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de 14 semanas de tratamiento para evaluar la eficacia, seguridad y tolerabilidad de Nerispirdina 50 mg, 100 mg y 200 mg en pacientes con Esclerosis Múltiple___________________________________________________________________A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients with Multiple Sclerosis | Esclerosis Múltiple______________Multiple Sclerosis MedDRA version: 11.0;Level: LLT;Classification code 10028245;Term: | Product Name: Nerispirdine hydrochloride Product Code: HP184 INN or Proposed INN: Nerispirdine hydrochloride | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 368 | Phase 2 | France;Finland;Spain;Germany | ||
| 383 | EUCTR2007-004122-24-GR (EUCTR) | 13/01/2009 | 30/01/2009 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 384 | EUCTR2007-001377-28-PT (EUCTR) | 09/01/2009 | 25/08/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 385 | EUCTR2007-005450-23-DE (EUCTR) | 29/12/2008 | 28/10/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection INN or Proposed INN: INTERFERON BETA-1A | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy | |||
| 386 | EUCTR2008-002096-27-LT (EUCTR) | 22/12/2008 | 16/07/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| 387 | NCT00811902 (ClinicalTrials.gov) | December 2008 | 18/12/2008 | Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis | A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis. | Multiple Sclerosis | Drug: Nerispirdine (HP184);Drug: placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 405 | Phase 2 | United States;Canada;Finland;France;Germany;Norway;Spain |
| 388 | EUCTR2008-002096-27-GB (EUCTR) | 28/11/2008 | 14/10/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| 389 | EUCTR2006-001152-12-SK (EUCTR) | 11/11/2008 | 16/04/2008 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 390 | NCT00744679 (ClinicalTrials.gov) | November 2008 | 29/8/2008 | A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State | An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions | Multiple Sclerosis | Drug: Natalizumab | Biogen Idec | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 20 | Phase 4 | United States |
| 391 | EUCTR2007-002627-32-NL (EUCTR) | 31/10/2008 | 11/07/2008 | A clinical study in which the efficacy and safety of 0.5 mg FTY720 versus placebo is evaluated vluated in patients with primary progressive multiple sclerosis. | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | |||
| 392 | EUCTR2007-004122-24-GB (EUCTR) | 14/10/2008 | 16/05/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 393 | EUCTR2006-001152-12-BG (EUCTR) | 17/09/2008 | 05/09/2008 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 394 | EUCTR2008-002096-27-PL (EUCTR) | 10/09/2008 | 25/06/2008 | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United Kingdom;Austria;Poland;Lithuania | |||
| 395 | EUCTR2007-001377-28-DE (EUCTR) | 01/09/2008 | 15/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 396 | NCT00772525 (ClinicalTrials.gov) | September 2008 | 13/10/2008 | Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis | A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis | Multiple Sclerosis;Optic Nerve;Neuritis | Drug: Nerispirdine (HP184);Drug: Placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 31 | Phase 2 | United States |
| 397 | EUCTR2006-003361-14-DK (EUCTR) | 29/08/2008 | 22/07/2008 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Finland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 398 | EUCTR2007-005450-23-LT (EUCTR) | 27/08/2008 | 07/05/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A (Avonex®) | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 399 | EUCTR2007-004122-24-FR (EUCTR) | 21/08/2008 | 03/06/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 400 | EUCTR2007-004122-24-SK (EUCTR) | 18/08/2008 | 23/04/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 401 | EUCTR2007-002627-32-BE (EUCTR) | 08/08/2008 | 20/08/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 402 | NCT00731692 (ClinicalTrials.gov) | July 28, 2008 | 7/8/2008 | This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. | A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 25 Years | 65 Years | All | 970 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic |
| 403 | EUCTR2007-004122-24-DE (EUCTR) | 22/07/2008 | 19/05/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | |||
| 404 | EUCTR2007-002627-32-ES (EUCTR) | 17/07/2008 | 08/05/2008 | Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos, para comparar la eficacia y seguridad de 1,25 mg FTY720 administrado por vía oral una vez al día versus placebo en pacientes con esclerosis múltiple primaria progresiva | Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos, para comparar la eficacia y seguridad de 1,25 mg FTY720 administrado por vía oral una vez al día versus placebo en pacientes con esclerosis múltiple primaria progresiva | Esclerosis múltiple primaria progresiva. MedDRA version: 9.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Farmacéutica S.A | NULL | Not Recruiting | Female: yes Male: yes | 650 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 405 | EUCTR2007-001377-28-NL (EUCTR) | 15/07/2008 | 29/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 406 | 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 | ||
| 407 | EUCTR2007-001377-28-AT (EUCTR) | 26/06/2008 | 27/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 408 | EUCTR2007-002627-32-SE (EUCTR) | 12/06/2008 | 28/04/2008 | A study to evaluate how safe and effective 0.5 mg FTY720 is in delayingdisability progression if taken once daily, in patients with PPMS | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - Efficacy and safety of 0.5 mg fingolimod in patients with PPMS | Primary progressive multiple sclerosis. MedDRA version: 17.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Services Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | France;Hungary;Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 409 | EUCTR2007-001377-28-FR (EUCTR) | 11/06/2008 | 29/02/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 410 | EUCTR2007-002627-32-FI (EUCTR) | 05/06/2008 | 22/04/2008 | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 940 | United States;Finland;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | |||
| 411 | EUCTR2007-005450-23-BG (EUCTR) | 29/05/2008 | 27/05/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Estonia;Bulgaria;Spain;Italy;Lithuania | |||
| 412 | EUCTR2007-003226-19-BG (EUCTR) | 22/05/2008 | 22/03/2008 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1419 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 413 | EUCTR2007-000888-15-ES (EUCTR) | 19/05/2008 | 27/02/2008 | ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple | ENSAYO CLÍNICO, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO,PARA COMPARAR LA EFICACIA CLÍNICA Y RADIOLÓGICA DE DOSIS EQUIVALENTES DEMETILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL O VÍA INTRAVENOSA ENPACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE - Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple | Pacientes afectos de esclerosis múltiple MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: SOLU-MODERIN 1 g INN or Proposed INN: METHYLPREDNISOLONE Trade Name: URBASON 40 mg comprimidos INN or Proposed INN: METHYLPREDNISOLONE | Servicio de Neurología | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 414 | EUCTR2007-004122-24-CZ (EUCTR) | 30/04/2008 | 03/01/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 415 | EUCTR2007-005450-23-CZ (EUCTR) | 14/04/2008 | 12/02/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 416 | EUCTR2007-005450-23-SK (EUCTR) | 10/04/2008 | 30/04/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Czech Republic;Estonia;Slovakia;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 417 | NCT00670449 (ClinicalTrials.gov) | April 2008 | 28/4/2008 | An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis | An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 143 | Phase 2 | Japan |
| 418 | EUCTR2007-005450-23-EE (EUCTR) | 28/03/2008 | 11/02/2008 | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection Product Name: - Product Code: - INN or Proposed INN: interferon beta-1a | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy | |||
| 419 | EUCTR2007-004122-24-NL (EUCTR) | 26/03/2008 | 28/02/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 420 | EUCTR2007-004122-24-BE (EUCTR) | 21/03/2008 | 13/02/2008 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 0,5 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 0,5 mg and 0.5 mg administered orally once daily versus placebo 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: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 421 | EUCTR2007-005450-23-ES (EUCTR) | 17/03/2008 | 29/01/2008 | Estudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVO | Estudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVO | Esclerosis Múltiple Remitente Recurrente (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Cápsulas de Laquinimod 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: Laquinimod Sodium (USAN) Trade Name: Avonex 30 microgramos/0.5 ml Solución para inyección | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 422 | NCT00629642 (ClinicalTrials.gov) | March 14, 2008 | 26/2/2008 | Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis | A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity | Multiple Sclerosis;Neurogenic Bladder;Spinal Cord Diseases | Drug: Solifenacin Succinate;Drug: Oxybutynin Hydrochloride;Drug: Placebo | Astellas Pharma Inc | NULL | Completed | 18 Years | 65 Years | All | 249 | Phase 4 | Australia;Belgium;Czechia;France;Germany;Hungary;Italy;Netherlands;Russian Federation;Spain;United Kingdom;Czech Republic;Portugal |
| 423 | EUCTR2006-003361-14-PT (EUCTR) | 07/03/2008 | 07/01/2008 | Multiple Sclerosis study to document the safety of two doses of teriflunomide | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 424 | EUCTR2005-000365-19-GB (EUCTR) | 19/02/2008 | 11/11/2005 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - CFTY720D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - CFTY720D2301 | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Hungary;Czech Republic;Slovakia;Greece;Finland;Ireland;Lithuania;Germany;United Kingdom;Sweden | ||
| 425 | EUCTR2006-003361-14-NL (EUCTR) | 12/02/2008 | 07/01/2008 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 426 | EUCTR2006-001152-12-EE (EUCTR) | 08/02/2008 | 21/11/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 427 | EUCTR2007-003226-19-PT (EUCTR) | 01/02/2008 | 24/10/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 428 | NCT00622700 (ClinicalTrials.gov) | February 2008 | 14/2/2008 | Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis | An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 618 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Turkey;Ukraine;United Kingdom;Brazil;Italy;Slovakia |
| 429 | NCT00662649 (ClinicalTrials.gov) | February 2008 | 17/4/2008 | Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod 0.5 mg;Drug: Fingolimod 1.25 mg | Novartis | NULL | Completed | 20 Years | 58 Years | All | 920 | Phase 3 | Australia;Belgium;Canada;Czech Republic;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Poland;Romania;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom;Israel;Netherlands |
| 430 | EUCTR2007-004122-24-SE (EUCTR) | 23/01/2008 | 19/12/2007 | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | INN or Proposed INN: fingolimod hydrochloride | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Estonia;Slovakia;Greece;Finland;Ireland;United Kingdom;France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Sweden | |||
| 431 | EUCTR2007-003226-19-LT (EUCTR) | 11/01/2008 | 25/09/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 432 | EUCTR2006-001152-12-HU (EUCTR) | 09/01/2008 | 09/10/2007 | Not applicable | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. - TOPIC | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 433 | EUCTR2006-001152-12-FR (EUCTR) | 08/01/2008 | 11/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 434 | NCT00464958 (ClinicalTrials.gov) | January 2008 | 22/4/2007 | One Year Extension Study To Protocol C2/5/TZ:MS-05 | Long Term Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in Patients With Multiple Sclerosis - Open Label Extension Study | Spasticity;Multiple Sclerosis | Drug: sublingual tizanidine 12 mg | Teva GTC | NULL | Terminated | 20 Years | 65 Years | Both | 10 | Phase 1/Phase 2 | Israel |
| 435 | EUCTR2007-003226-19-SE (EUCTR) | 27/12/2007 | 29/10/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Sweden;Lithuania;United Kingdom;Czech Republic;Estonia;Spain | |||
| 436 | EUCTR2007-003226-19-IT (EUCTR) | 06/12/2007 | 10/03/2008 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - Allegro | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - Allegro | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: laquinimod Product Code: TV-5600 INN or Proposed INN: laquinimod | TEVA ITALIA srl | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 437 | EUCTR2006-001152-12-DK (EUCTR) | 05/12/2007 | 30/10/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 438 | EUCTR2007-003226-19-EE (EUCTR) | 04/12/2007 | 10/10/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 439 | NCT00509145 (ClinicalTrials.gov) | December 2007 | 27/7/2007 | Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) | A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Drug: Laquinimod;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | Both | 1106 | Phase 3 | United States;Austria;Bulgaria;Canada;Czech Republic;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Former Serbia and Montenegro;Spain;Sweden;Turkey;Ukraine;United Kingdom;Portugal |
| 440 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |
| 441 | EUCTR2007-003226-19-ES (EUCTR) | 22/11/2007 | 04/10/2007 | Estudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - Allegro | Estudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - Allegro | Esclerosis Múltiple Remitente Recurrente (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | ||
| 442 | EUCTR2007-003226-19-LV (EUCTR) | 06/11/2007 | 12/09/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 443 | EUCTR2007-003226-19-CZ (EUCTR) | 25/10/2007 | 10/09/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;Czech Republic;United Kingdom;Estonia;Spain | |||
| 444 | EUCTR2007-003226-19-GB (EUCTR) | 24/10/2007 | 01/08/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 445 | EUCTR2006-001152-12-GB (EUCTR) | 24/10/2007 | 14/10/2010 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | ||
| 446 | EUCTR2007-003226-19-DE (EUCTR) | 23/10/2007 | 15/07/2008 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | |||
| 447 | EUCTR2006-001152-12-CZ (EUCTR) | 15/10/2007 | 07/08/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | ||
| 448 | EUCTR2006-001152-12-FI (EUCTR) | 15/10/2007 | 11/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 449 | EUCTR2007-003226-19-HU (EUCTR) | 09/10/2007 | 13/07/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 450 | EUCTR2006-001152-12-AT (EUCTR) | 04/10/2007 | 20/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 451 | NCT00548405 (ClinicalTrials.gov) | October 2007 | 22/10/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two | A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy | Multiple Sclerosis, Relapsing-Remitting | Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg;Biological: Interferon beta-1a | Genzyme, a Sanofi Company | Bayer | Completed | 18 Years | 55 Years | All | 840 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czech Republic;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom |
| 452 | EUCTR2007-003226-19-AT (EUCTR) | 30/09/2007 | 19/09/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 453 | EUCTR2007-003226-19-FR (EUCTR) | 21/09/2007 | 06/08/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | ||
| 454 | EUCTR2007-003226-19-NL (EUCTR) | 05/09/2007 | 12/07/2007 | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1419 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 455 | NCT00537082 (ClinicalTrials.gov) | September 2007 | 26/9/2007 | Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS) | A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: FTY720;Drug: Placebo | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 171 | Phase 2 | Japan |
| 456 | EUCTR2006-003361-14-SE (EUCTR) | 24/07/2007 | 27/06/2007 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 457 | EUCTR2007-000236-16-LV (EUCTR) | 04/07/2007 | 02/04/2007 | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | Established Spasticity Resulting from Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity | Product Code: IPX056-40 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-35 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-30 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-25 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-20 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-10 mg INN or Proposed INN: BACLOFEN Trade Name: baclofen Product Name: baclofen Product Code: baclofen 20 mg INN or Proposed INN: BACLOFEN | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Estonia;Latvia | |||
| 458 | NCT00467584 (ClinicalTrials.gov) | July 2007 | 26/4/2007 | Aspirin for Treatment of Multiple Sclerosis-Related Fatigue | Aspirin for Treatment of Multiple Sclerosis-Related Fatigue | Multiple Sclerosis;Fatigue | Drug: High Dose Aspirin (1300 mg/day);Drug: Low Dose Aspirin (162 mg/day);Drug: Placebo | Mayo Clinic | National Multiple Sclerosis Society | Terminated | 18 Years | 65 Years | All | 62 | Phase 3 | United States |
| 459 | EUCTR2006-005972-42-DE (EUCTR) | 20/06/2007 | 15/08/2007 | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: NA Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF Product Code: NA INN or Proposed INN: Interferon beta-1a Other descriptive name: recombinant human IFN beta Trade Name: Ibuprofen Sandoz 400 mg Filmtabletten Product Name: Ibuprofen INN or Proposed INN: Ibuprofen | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | Germany;France | ||
| 460 | NCT00488839 (ClinicalTrials.gov) | June 2007 | 18/6/2007 | IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the PK and PD of IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis | Multiple Sclerosis | Drug: IPX056 20 mg;Drug: IPX056 40 mg;Drug: Encapsulated Baclofen 20 mg;Drug: Placebo Baclofen Tablet;Drug: IPX056 10 mg;Drug: IPX056 30 mg;Drug: IPX056 35 mg;Drug: Placebo IPX056 20 mg;Drug: Placebo IPX056 40 mg | Impax Laboratories, LLC | NULL | Completed | 18 Years | N/A | All | 173 | Phase 3 | United States;Canada;Estonia;Latvia;Ukraine |
| 461 | EUCTR2007-000236-16-EE (EUCTR) | 28/05/2007 | 16/03/2007 | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Established Spasticity Resulting from Multiple Sclerosis | Established Spasticity Resulting from Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10041416;Term: Spasticity | Product Code: IPX056-40 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-35 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-30 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-20 mg INN or Proposed INN: BACLOFEN Product Code: IPX056-10 mg INN or Proposed INN: BACLOFEN Trade Name: baclofen Product Name: baclofen Product Code: baclofen 20 mg INN or Proposed INN: BACLOFEN | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Estonia;Latvia | |||
| 462 | EUCTR2006-003361-14-IT (EUCTR) | 23/05/2007 | 07/03/2007 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D Product Name: teriflunomide Product Code: HMR1726D | sanofi-aventis recherche de veloppement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 463 | EUCTR2005-000365-19-LT (EUCTR) | 11/05/2007 | 27/03/2007 | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720 Product Name: FTY720 Product Code: FTY720 | NovartisPharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Sweden;Lithuania | |||
| 464 | NCT00483652 (ClinicalTrials.gov) | May 2007 | 6/6/2007 | Study of Fampridine-SR Tablets in Multiple Sclerosis Patients | Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine-SR;Drug: Placebo | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 240 | Phase 3 | United States;Canada |
| 465 | EUCTR2005-000365-19-EE (EUCTR) | 26/04/2007 | 01/03/2007 | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | A 24A 24-month, double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis | Remitting-relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720 Product Name: FTY720 Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 466 | EUCTR2006-000704-17-BE (EUCTR) | 25/04/2007 | 06/07/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Greece;Spain;Belgium;Austria;Germany;Italy;United Kingdom | |||
| 467 | EUCTR2006-000704-17-HU (EUCTR) | 16/04/2007 | 27/07/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 468 | EUCTR2005-000365-19-IE (EUCTR) | 30/03/2007 | 18/01/2007 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 469 | EUCTR2005-000365-19-GR (EUCTR) | 13/03/2007 | 02/10/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 470 | EUCTR2006-003361-14-DE (EUCTR) | 01/03/2007 | 28/12/2006 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United States;Portugal;Estonia;Finland;Ukraine;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Sweden | |||
| 471 | NCT01111656 (ClinicalTrials.gov) | March 2007 | 15/3/2010 | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b | SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study (SWABIMS Follow Up-study) | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b group;Drug: Interferon beta-1b/Atorvastatin group | University Hospital Inselspital, Berne | Viollier AG, Basel, Switzerland;PharmaPart GmbH, Thalwil, Switzerland | Completed | 18 Years | 67 Years | Both | 28 | Phase 2 | Switzerland |
| 472 | EUCTR2006-002037-20-EE (EUCTR) | 02/02/2007 | 04/12/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: glatiramer acetate Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 473 | NCT00845338 (ClinicalTrials.gov) | February 2007 | 16/2/2009 | Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity | A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity | Multiple Sclerosis;Overactive Detrusor | Drug: Darifenacin (BAY79-4998) | Bayer | NULL | Terminated | 18 Years | N/A | Both | 7 | Phase 2 | Germany |
| 474 | NCT00501696 (ClinicalTrials.gov) | February 2007 | 12/7/2007 | A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone | A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone on Quality of Life as Measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI54) | Multiple Sclerosis | Drug: 4.5 mg Naltrexone;Drug: Naltrexone | University of California, San Francisco | NULL | Completed | 18 Years | 86 Years | Both | 80 | Phase 3 | United States |
| 475 | EUCTR2005-000365-19-HU (EUCTR) | 25/01/2007 | 22/09/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Finland;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 476 | EUCTR2006-003361-14-GB (EUCTR) | 23/01/2007 | 29/09/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 477 | EUCTR2006-003361-14-FI (EUCTR) | 19/12/2006 | 10/11/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 478 | EUCTR2006-000704-17-GR (EUCTR) | 19/12/2006 | 11/08/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod Product Name: Interferon beta-1a INN or Proposed INN: interferon beta-1a | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Phase 3 | Portugal;Hungary;Greece;Belgium;Spain;Austria;Germany;Italy;United Kingdom | ||
| 479 | EUCTR2006-002633-20-ES (EUCTR) | 01/12/2006 | 13/04/2012 | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Esclerosis múltiple remitente-recurrente MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline S.A | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Finland;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Norway;New Zealand | ||
| 480 | EUCTR2006-002361-39-DE (EUCTR) | 01/12/2006 | 21/08/2006 | A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity | A 4-week, open-label, multicenter, urodynamic pilot study to explore the efficacy, tolerability and safety of darifenacin (7.5 mg with up-titration to 15 mg) in patients with multiple sclerosis and neurogenic detrusor overactivity | Neurogenic overactive bladder disaese in patients with multiple sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10059617;Term: Overactive bladder | Trade Name: EMSELEX 7,5 mg Retardtabletten Product Name: Darifenacin Product Code: BAY 79-4998 INN or Proposed INN: Darifenacin Trade Name: EMSELEX 15 mg Retardtabletten Product Name: Darifenacin Product Code: BAY 79-4998 INN or Proposed INN: Darifenacin | Bayer Vital GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 481 | NCT00358293 (ClinicalTrials.gov) | December 2006 | 27/7/2006 | Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity | A Double-Blind, Randomized, Crossover Study to Evaluate the Clinical Efficacy and Safety of Oral Tizanidine HCl (12 mg) Versus Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in MS Patients | Muscle Spasticity | Drug: Tizanidine (sublingual or oral) | Teva GTC | NULL | Completed | 20 Years | 65 Years | Both | 20 | Phase 1/Phase 2 | Israel |
| 482 | 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 |
| 483 | EUCTR2006-002037-20-LT (EUCTR) | 30/11/2006 | 09/10/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate Trade Name: Copaxone 20mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: glatiramer acetate Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 484 | EUCTR2006-003361-14-AT (EUCTR) | 21/11/2006 | 10/10/2006 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United States;Portugal;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 485 | EUCTR2006-000704-17-PT (EUCTR) | 09/11/2006 | 02/08/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional extension phase - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional extension phase - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: Fingolimod Trade Name: Avonex Product Name: Interferon beta-1a INN or Proposed INN: interferon beta-1a | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Hungary;Portugal;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 486 | EUCTR2006-000704-17-GB (EUCTR) | 19/10/2006 | 10/05/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod Product Name: Interferon beta-1a INN or Proposed INN: interferon beta-1a Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 487 | EUCTR2006-002037-20-CZ (EUCTR) | 13/10/2006 | 28/08/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml, Solution for Injection, pre-filled syringes Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 488 | NCT00803049 (ClinicalTrials.gov) | October 2006 | 1/12/2008 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide (HMR1726) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 742 | Phase 3 | United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 489 | EUCTR2006-002037-20-BE (EUCTR) | 27/09/2006 | 19/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 490 | 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 | |||
| 491 | EUCTR2006-000704-17-IT (EUCTR) | 15/09/2006 | 06/11/2009 | A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | A 12-month double-blind, randomized, multicenter, active-controlled, parallel-group study comparing the efficacy and safety of two doses of fingolimod FTY720 0.5 mg and 1.25 mg administered orally once daily versus interferon beta-1a Avonex administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 | Relapsing-remitting multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: fingolimod Product Code: FTY720D Product Name: fingolimod Product Code: FTY720D INN or Proposed INN: Interferon beta-1a | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 492 | EUCTR2006-000704-17-AT (EUCTR) | 08/09/2006 | 12/07/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria | |||
| 493 | EUCTR2006-002037-20-DE (EUCTR) | 07/09/2006 | 20/10/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Czech Republic;United Kingdom;Germany;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 494 | EUCTR2006-002037-20-GB (EUCTR) | 07/09/2006 | 23/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 495 | EUCTR2006-002037-20-ES (EUCTR) | 06/09/2006 | 07/07/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: Glatiramer acetato Trade Name: Copaxone 20 mg/ml solución para inyección en jeringa precargada Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: GLATIRAMERO ACETATO Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom | ||
| 496 | EUCTR2006-002037-20-LV (EUCTR) | 06/09/2006 | 23/08/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: glatiramer acetate Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: glatiramer acetate Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 497 | 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 | |||
| 498 | NCT00398528 (ClinicalTrials.gov) | September 2006 | 9/11/2006 | An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis | An fMRI Study of Treatment Optimization Recommendations Comparing Patients Changing Treatment From Glatiramer Acetate 20 mg qd SC (Copaxone®) to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Those Changing From to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Glatiramer Acetate 20 mg qd SC (Copaxone®) in a Multicenter Study of Patients With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy. | Relapsing-Remitting Multiple Sclerosis | Drug: Glatiramer acetate, (Copaxone®);Drug: IFN-ß-1a, (Avonex®) | Neurognostics | NULL | Terminated | 18 Years | 65 Years | Both | 48 | United States | |
| 499 | 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 | |||
| 500 | EUCTR2006-000704-17-DE (EUCTR) | 21/08/2006 | 12/06/2006 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 | A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: Fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Portugal;Hungary;United Kingdom;Germany;Belgium;Spain;Italy;Greece;Austria | |||
| 501 | NCT00337779 (ClinicalTrials.gov) | August 2006 | 14/6/2006 | Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA). | A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS) | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate (GA) 40 mg;Drug: glatiramer acetate 20 mg | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | All | 1155 | Phase 3 | Argentina;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain;United Kingdom;United States |
| 502 | EUCTR2006-002037-20-HU (EUCTR) | 27/07/2006 | 23/05/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 503 | EUCTR2005-000365-19-FI (EUCTR) | 14/07/2006 | 16/06/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 504 | EUCTR2006-002037-20-IT (EUCTR) | 12/07/2006 | 30/08/2006 | A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE | A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE | Patients with Relapsing - Remitting Multiple Sclerosis. MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: 40 mg Glatiramer acetato Product Code: 40 mg GA INN or Proposed INN: Glatiramer acetate Trade Name: COPAXONE*SC 28SIR 20MG/ML INN or Proposed INN: Glatiramer acetate | Teva Pharmaceuticals Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 505 | EUCTR2006-002037-20-FI (EUCTR) | 12/07/2006 | 15/06/2006 | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE | Relapsing-remitting Multiple Sclerosis (RR MS) MedDRA version: 8.1;Level: PT;Classification code 10028245 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA INN or Proposed INN: n.a. Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe Product Code: 20 mg GA INN or Proposed INN: n.a. Other descriptive name: Copaxone | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 980 | Phase 3 | Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom | ||
| 506 | EUCTR2005-000365-19-SK (EUCTR) | 23/06/2006 | 05/05/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 INN or Proposed INN: fingolimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | Estonia;Hungary;Czech Republic;Slovakia;Greece;Finland;Ireland;Lithuania;Germany;United Kingdom;Sweden | ||
| 507 | EUCTR2005-004061-41-GB (EUCTR) | 01/06/2006 | 25/10/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI 300 mg concentrate for solution for infusion Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 508 | NCT00355134 (ClinicalTrials.gov) | June 2006 | 19/7/2006 | Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis | 24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase | Multiple Sclerosis | Drug: Fingolimod;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 55 Years | All | 1083 | Phase 3 | United States;Australia;Austria;Canada;Poland;Romania;Turkey;United Kingdom;Lithuania |
| 509 | EUCTR2005-000365-19-DE (EUCTR) | 03/05/2006 | 25/01/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Hungary;Finland;Czech Republic;United Kingdom;Germany;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 510 | NCT00340834 (ClinicalTrials.gov) | May 2006 | 19/6/2006 | Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase | A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase | Multiple Sclerosis | Drug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: Interferon ß-1a 30 µg | Novartis | NULL | Completed | 18 Years | 55 Years | All | 1292 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Egypt;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico |
| 511 | EUCTR2005-004334-41-CZ (EUCTR) | 13/02/2006 | 12/01/2006 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Hungary;Czech Republic;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 512 | EUCTR2005-004334-41-GB (EUCTR) | 10/02/2006 | 31/10/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Poland;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 513 | EUCTR2005-000365-19-CZ (EUCTR) | 02/02/2006 | 11/01/2006 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. | Relapsing-remitting multiple sclerosis. MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 Product Name: FTY720 Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;United Kingdom;Czech Republic;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 514 | NCT00382629 (ClinicalTrials.gov) | February 2006 | 27/9/2006 | BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis | BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BHT-3009 0.5 mg;Drug: BHT-3009 1.5 mg;Drug: Placebo | Bayhill Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 252 | Phase 2 | NULL |
| 515 | EUCTR2005-004289-18-FI (EUCTR) | 26/01/2006 | 07/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 516 | EUCTR2005-004334-41-DE (EUCTR) | 11/01/2006 | 21/11/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 517 | EUCTR2005-004334-41-ES (EUCTR) | 04/01/2006 | 10/11/2005 | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 310 | Phase 2 | Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom | ||
| 518 | EUCTR2005-004289-18-SE (EUCTR) | 04/01/2006 | 10/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 519 | NCT00289978 (ClinicalTrials.gov) | January 2006 | 9/2/2006 | Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Fingolimod 1.25 mg;Drug: Fingolimod 0.5 mg;Drug: Placebo | Novartis | NULL | Completed | 18 Years | 55 Years | All | 1272 | Phase 3 | Australia;Belgium;Canada;Czech Republic;Finland;France;Germany;Greece;Israel;Lithuania;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Sweden;Switzerland;Turkey;United Kingdom;Italy |
| 520 | EUCTR2005-004334-41-HU (EUCTR) | 20/12/2005 | 04/11/2005 | An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease. | An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Capsules 0.6 mg Product Code: TV-5600 INN or Proposed INN: Laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 521 | EUCTR2005-004289-18-DK (EUCTR) | 19/12/2005 | 28/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | E. Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Denmark;Sweden | |||
| 522 | EUCTR2005-000365-19-SE (EUCTR) | 19/12/2005 | 02/11/2005 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | A 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis - D2301 | Relapsing-remitting multiple sclerosis (RRMS) | Product Code: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Hungary;Finland;Germany;Czech Republic;United Kingdom;Estonia;Ireland;Greece;Lithuania;Sweden | |||
| 523 | NCT00745615 (ClinicalTrials.gov) | December 7, 2005 | 2/9/2008 | An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease | An Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL) | Relapsing Remitting Multiple Sclerosis | Drug: Laquinimod;Drug: Placebo | Teva Pharmaceutical Industries, Ltd. | NULL | Terminated | 18 Years | 50 Years | All | 257 | Phase 2 | Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czech Republic |
| 524 | EUCTR2005-004334-41-IT (EUCTR) | 30/11/2005 | 01/03/2006 | An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Laquinimod Product Code: ABR-215062 INN or Proposed INN: LAQUINIMOD | Teva Pharmaceutical Industries Ldt | NULL | Not Recruiting | Female: yes Male: yes | 246 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy | ||
| 525 | EUCTR2005-003410-15-SE (EUCTR) | 21/11/2005 | 29/09/2005 | A twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MS | A twelve-month double-blind placebo-controlled cross-over study of the effect ofAricept treatment on cognitive dysfunction in multiple sclerosis. - Aricept in MS | Multiple sclerosis is a devastating inflammation in the central nervous system and it can often give cognitive dysfunction, affecting memory, mental concentration. Lately it has been shown that the cognitive dysfunction has a big impact on life quality. Immunomodulatory medication can only partially limit the bouts but there is no effective cure at the moment. There is little options to treat the effects on higher functions for the moment. | Trade Name: Aricept 5 mg filmdragerade tabletter Product Name: Aricept 5 mg INN or Proposed INN: Donepezil Trade Name: Aricept 10 mg filmdragerade tabletter Product Name: Aricept 10 mg INN or Proposed INN: Donepezil | Neurology Unit | NULL | Not Recruiting | Female: yes Male: yes | 20 | Sweden | |||
| 526 | EUCTR2005-006071-12-IT (EUCTR) | 31/08/2005 | 09/05/2006 | Evaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCE | Evaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCE | MULTIPLE SCLEROSIS MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: EPARMEFOLIN 30 CPR 0,1/0,5MG INN or Proposed INN: CALCIO FOLINATO DC.IT INN or Proposed INN: CIANOCOBALAMINA FU DC.IT Trade Name: LEVOFOLENE 4 MG 30 CPR INN or Proposed INN: Calcium levofolinate | AZIENDA OSPEDALIERA SAN CAMILLO FORLANINI | NULL | Not Recruiting | Female: yes Male: yes | 276 | Italy | |||
| 527 | EUCTR2005-001009-25-IT (EUCTR) | 16/07/2005 | 15/03/2006 | Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNA | Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNA | Multiple sclerosis treatment 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] | Trade Name: TORVAST*10CPR 10MG INN or Proposed INN: Atorvastatin Trade Name: TORVAST*10CPR 10MG INN or Proposed INN: Atorvastatin | DR DIMENSIONE RICERCA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 528 | NCT00942591 (ClinicalTrials.gov) | May 2005 | 17/7/2009 | Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis. | Multiple Sclerosis | Drug: Interferon beta 1b;Drug: Atorvastatin | University Hospital Inselspital, Berne | CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel | Completed | 18 Years | 55 Years | Both | 77 | Phase 2 | Switzerland |
| 529 | EUCTR2004-003943-28-DE (EUCTR) | 06/04/2005 | 14/09/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
| 530 | NCT00213135 (ClinicalTrials.gov) | April 2005 | 13/9/2005 | A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Cladribine 5.25 mg/kg;Drug: Cladribine 3.5 mg/kg;Other: Placebo | EMD Serono | NULL | Completed | 18 Years | 65 Years | All | 1326 | Phase 3 | Canada;Switzerland |
| 531 | EUCTR2004-003943-28-CZ (EUCTR) | 21/03/2005 | 09/02/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy | |||
| 532 | EUCTR2004-003943-28-GB (EUCTR) | 18/02/2005 | 22/02/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom | ||
| 533 | EUCTR2004-003943-28-ES (EUCTR) | 17/02/2005 | 09/12/2005 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy | ||
| 534 | EUCTR2004-004130-14-AT (EUCTR) | 17/02/2005 | 13/01/2005 | A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week). | A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week). | Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week). | Product Name: Natalizumab Product Code: Not Applicable INN or Proposed INN: natalizumab Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: Interferon beta-1a | Biogen Idec GmbH | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Austria | |||
| 535 | EUCTR2004-003943-28-HU (EUCTR) | 14/02/2005 | 13/12/2004 | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects | Relapsing Remitting Multiple Sclerosis MedDRA version: 5.1;Level: PT;Classification code 10028245 | Product Name: Laquinimod Tablets 0.3 mg Product Code: ABR-215062 sodium salt INN or Proposed INN: laquinimod Other descriptive name: PNU-215062 sodium salt | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 265 | Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy | |||
| 536 | NCT00101959 (ClinicalTrials.gov) | November 2004 | 18/1/2005 | Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) Subjects | An Implementation Study of Treatment Optimization Recommendations Comparing Subjects Continuing Treatment With IFN-ß-1a 30 Mcg qw IM (Avonex®) or Glatiramer Acetate 20 mg qd SC (Copaxone®) to Those Randomized to IFN-ß-1a 44 Mcg Tiw SC (Rebif®), in a Multicenter Study of Subjects With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy | Relapsing-Remitting Multiple Sclerosis | Drug: Rebif | EMD Serono | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 4 | United States |
| 537 | EUCTR2004-000759-40-IT (EUCTR) | 22/10/2004 | 15/02/2005 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit. MedDRA version: 6.1;Level: PT;Classification code 10028245 | Product Name: glatiramer acetate Product Code: TV-5010 INN or Proposed INN: Glatiramer acetate | TEVA | NULL | Not Recruiting | Female: yes Male: yes | 25 | Italy | |||
| 538 | EUCTR2004-000762-13-IT (EUCTR) | 31/08/2004 | 31/08/2012 | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. | Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit. MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Glatiramer acetate Product Code: TV-5010 INN or Proposed INN: Glatiramer acetate | TEVA ITALIA srl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 7 | Italy | |||
| 539 | NCT00078338 (ClinicalTrials.gov) | March 2004 | 23/2/2004 | Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis | Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Human interferon beta-1a and glatiramer acetate | EMD Serono | Pfizer | Completed | 18 Years | 60 Years | Both | 764 | Phase 4 | United States;Argentina;Austria;Brazil;France;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;United Kingdom |
| 540 | NCT00099502 (ClinicalTrials.gov) | November 2003 | 15/12/2004 | BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients | International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily. | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046);Drug: Copaxone | Bayer | NULL | Completed | 18 Years | 55 Years | Both | 2244 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine |
| 541 | NCT00202982 (ClinicalTrials.gov) | August 2003 | 12/9/2005 | A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose | A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients | Relapse-Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mg | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 90 | Phase 2 | United States |
| 542 | NCT00203073 (ClinicalTrials.gov) | June 2003 | 13/9/2005 | A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis. | A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantrone | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 55 Years | Both | 40 | Phase 2 | United States;Canada |
| 543 | NCT00053417 (ClinicalTrials.gov) | February 2003 | 29/1/2003 | Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis | Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP) | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 206 | Phase 2 | United States;Canada |
| 544 | 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 |
| 545 | NCT00050778 (ClinicalTrials.gov) | December 2002 | 19/12/2002 | A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: Interferon beta-1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg | Genzyme, a Sanofi Company | Bayer | Completed | 18 Years | 50 Years | All | 334 | Phase 2 | United States;Croatia;Poland;Russian Federation;United Kingdom |
| 546 | NCT00405353 (ClinicalTrials.gov) | April 2002 | 28/11/2006 | Testosterone Treatment for Multiple Sclerosis | Testosterone Treatment for Multiple Sclerosis: A Preliminary Trial | Multiple Sclerosis | Drug: Androgel 10 grams of gel containing 100 mg of testosterone | University of California, Los Angeles | National Multiple Sclerosis Society | Completed | 18 Years | 65 Years | Male | 10 | Phase 1/Phase 2 | United States |
| 547 | EUCTR2012-003056-36-NL (EUCTR) | 21/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 1530 | Phase 3 | Belgium;Poland;Romania;Bulgaria;Germany;Sweden;Argentina;Canada;Hungary;Czech Republic;Egypt;United Kingdom;Austria;Lithuania;Turkey;Latvia;Netherlands;Australia;France;Italy;Switzerland;Russian Federation;Israel;Ireland;Spain;Greece;Slovakia;Estonia;Portugal;United States | |||
| 548 | EUCTR2007-002627-32-DE (EUCTR) | 26/05/2008 | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis. - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis | Primary progressive multiple sclerosis. MedDRA version: 17.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Gilenya 0,5 mg Hartkapseln Product Name: Fingolimod Product Code: FTY720D INN or Proposed INN: Fingolimod Other descriptive name: FTY720 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 970 | United States;Finland;Spain;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Sweden |