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 | 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 | ||
| 2 | NCT03847545 (ClinicalTrials.gov) | December 12, 2018 | 19/12/2018 | Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking Technique | Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking | Multiple Sclerosis | Drug: Fampridine | University of Southern Denmark | Odense University Hospital;Sygehus Lillebaelt;Region of Southern Denmark;The Augustinus Foundation, Denmark.;Lounkær Fonden;Fonden for scleroseramte på Fyn;The Danish Multiple Sclerosis Society;TH MAIGAARDS EFTF. FRU LILY BENTHINE LUNDS FOND AF 1. JUNI 1978;Fonden til Lægevidenskabens Fremme;Overlægeråds forskningsfond | Recruiting | 18 Years | 100 Years | All | 60 | N/A | Denmark |
| 3 | NCT03164018 (ClinicalTrials.gov) | March 7, 2017 | 29/3/2017 | Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis | Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis | Multiple Sclerosis | Drug: Fampridine | Genesis Pharma CNS & Specialty | NULL | Completed | 18 Years | N/A | All | 111 | Greece | |
| 4 | EUCTR2014-003498-41-AT (EUCTR) | 22/09/2015 | 06/08/2015 | Effects of dalfampridine on mobility in the context of daily life | Effects of dalfampridine on mobility in the context of daily life - Fampridine Study in Activities of Daily Living | Motor behaviour and cognition in multiple sclerosis patients;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra INN or Proposed INN: FAMPRIDINE | Medical University of Vienna | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | ||||
| 5 | NCT01532154 (ClinicalTrials.gov) | August 2015 | 15/12/2011 | Fampridine Pregnancy Exposure Registry | Fampridine Pregnancy Exposure Registry | Multiple Sclerosis;Pregnancy | Drug: Fampridine | Biogen | NULL | Terminated | N/A | N/A | Female | 1 | N/A | France;Germany;United Kingdom;United States |
| 6 | 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 | ||
| 7 | 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 | ||||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | |||
| 12 | 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 | |||
| 13 | 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 |
| 14 | 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 | |||
| 15 | NCT02143167 (ClinicalTrials.gov) | May 2014 | 9/5/2014 | Resistance Training and Amino Pyridine in Multiple Sclerosis | RETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: SR-fampridine;Drug: Placebo | University of Southern Denmark | Region of Southern Denmark;Biogen | Completed | 18 Years | 60 Years | All | 40 | Phase 4 | Denmark |
| 16 | NCT02208050 (ClinicalTrials.gov) | February 21, 2014 | 19/5/2014 | A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS | A Phase IV Double Blind, Randomized, Placebo Controlled, Crossover Study of the Effectiveness of Oral Fampridine in Improving Upper Limb Function in Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Fampridine;Drug: Placebo | University College Dublin | NULL | Completed | 18 Years | 70 Years | All | 64 | Phase 4 | Ireland |
| 17 | NCT02849782 (ClinicalTrials.gov) | February 4, 2014 | 22/7/2016 | Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine. | Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor Performances | Multiple Sclerosis | Drug: Fampridine | Centre Hospitalier Universitaire de Besancon | NULL | Completed | 18 Years | 80 Years | All | 89 | Phase 4 | France |
| 18 | EUCTR2013-002558-64-IT (EUCTR) | 18/12/2013 | 16/10/2013 | improvement of cognitive performance after administration of fampridina in patients with multiple sclerosis | A randomised, placebo-controlled trial investigating the role of fampiridina in improving cognitive function of patients with multiple sclerosis. | MULTIPLE SCLEROSIS MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: fampyra Product Name: FAMPYRA INN or Proposed INN: FAMPRIDINE | dipartimento di neurologia e psichiatria | NULL | Not Recruiting | Female: yes Male: yes | 123 | Phase 4 | Italy | ||
| 19 | NCT02146534 (ClinicalTrials.gov) | December 2013 | 23/4/2014 | Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients | Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: a Phase IV, Double-blind, Placebo-controlled Study. | Multiple Sclerosis | Drug: extended release fampridine;Drug: Placebo | Clinique Neuro-Outaouais | CogState Ltd. | Completed | 18 Years | N/A | All | 44 | Phase 4 | Canada |
| 20 | EUCTR2013-000529-30-GB (EUCTR) | 27/11/2013 | 17/10/2013 | prolonged-release oral fampridine in Neuromyelitis Optica (NMO), Pilot feasibility Study | A pilot study to assess efficacy of prolonged-Release oral fampridine on ambulation and visual function in Neuromyelitis Optica - Assessment of fampridine-PR in NMO | Neuromyelitis optica (NMO);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: fampyra 10mg prolonged release tablets | Walton Centre Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 21 | EUCTR2013-001409-10-DK (EUCTR) | 08/08/2013 | 06/08/2013 | Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MS | FATIMS - Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MS - FATIMS | Multiple Sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE | Odense University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Denmark | |||
| 22 | NCT01917019 (ClinicalTrials.gov) | August 2013 | 2/8/2013 | A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis | A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety Extension | Multiple Sclerosis, Remittent Progressive;Multiple Sclerosis, Primary Progressive;Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Multiple Sclerosis | Drug: Placebo;Drug: BIIB041 (fampridine) | Biogen | NULL | Completed | 18 Years | 70 Years | All | 101 | Phase 3 | Japan |
| 23 | EUCTR2011-002959-34-DK (EUCTR) | 11/03/2013 | 01/03/2013 | RETRAP - A study of the effect of combination of resistance training and prolonged-release fampridine on muscle strength in the legs, walking capacity and quality of life in multiple sclerosis patients. | RETRAP - A double blind, randomized, placebo controlled study of the effect of the combination of resistance training and prolonged release fampridine on muscle strength in the lower extremities, walking capacity and quality of life in relapsing remitting multiple sclerosis - RETRAP | Multiple sclerosis MedDRA version: 15.1;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: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE | Sønderjylland Hospital, department of neurology | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 4 | Denmark | ||
| 24 | EUCTR2012-005076-34-BE (EUCTR) | 03/01/2013 | 14/12/2012 | Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters.A cross-over, double-blinded, placebo-controlled study. | Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters.A cross-over, double-blinded, placebo-controlled study. | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 | Cliniques Universitaires Saint-Luc, Neurologie | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 25 | 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 | |||
| 26 | NCT01667497 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? | Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? A Cross Over Study | Cognitive Fatigue | Drug: Fampridine SR;Drug: Placebo | London Health Sciences Centre | NULL | Completed | 18 Years | 64 Years | Both | 60 | Phase 2/Phase 3 | Canada |
| 27 | 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 | ||
| 28 | 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 |
| 29 | 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 | |||
| 30 | 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 | |||
| 31 | NCT01656148 (ClinicalTrials.gov) | June 2012 | 31/7/2012 | FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra | Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of Fampyra | Multiple Sclerosis | Drug: Fampridine-SR | University of Southern Denmark | Region of Southern Denmark;Biogen | Completed | 18 Years | 60 Years | All | 108 | Phase 4 | Denmark |
| 32 | EUCTR2012-000287-17-IT (EUCTR) | 21/05/2012 | 18/06/2012 | functional MRI study to evaluate improvement of hand performance after combined motor exercise and aminopiridine assumption | PROMOTION OF FUNCTIONAL RESTORATION THROUGH PHARMACOLOGICAL MODULATION OF BRAIN PLASTICITY WITH AMINOPYRIDINE IN PATIENTS WITH MULTIPLE SCLEROSIS STUDIED BY FUNCTIONAL MRI | Patients with MS, without relevant medical conditions, with right upper limb impairment assessed by a hand dexterity test will be included.Patients will be in a non-active phase of the disease and under a stable pharmacological treatment.They will not be included if they have received physiotherapy in the previous few months. Healthy volunteers will be recruited if they have no relevant medical condition and no contraindication to perform a MRI scan. MedDRA version: 14.1;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FAMPYRA INN or Proposed INN: FAMPRIDINE | FONDAZIONE SANTA LUCIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 33 | NCT01480063 (ClinicalTrials.gov) | April 16, 2012 | 23/11/2011 | An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice | A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE) | Multiple Sclerosis | Drug: Fampridine | Biogen | NULL | Completed | N/A | N/A | All | 4734 | Argentina;Canada;Czechia;France;Germany;Ireland;Israel;Lebanon;Netherlands;Norway;Portugal;Spain;United Arab Emirates;Australia;Belgium;Czech Republic;Denmark | |
| 34 | EUCTR2011-002561-38-IE (EUCTR) | 30/03/2012 | 09/02/2012 | Trial on the effectiveness of Fampridine medication for upper limb function in people with MS. | A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis. | 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 10053395;Term: Progressive multiple sclerosis;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra Product Code: SUB0750MIG INN or Proposed INN: FAMPRIDINE | St. Vincent's University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | Ireland | ||
| 35 | NCT01576354 (ClinicalTrials.gov) | March 2012 | 22/3/2012 | Characterization of the Effects of Prolonged-release Fampridine on Ambulatory Function in Patients With Multiple Sclerosis | A Phase IIb, Double-blind, Randomized, Mono-center, Placebo-controlled Study With Crossover Design Characterizing the Effects of Prolonged-release Fampridine Treatment on Ambulatory Function in Patients With Multiple Sclerosis Using Detailed Gait Analysis Based on Kinematic and Kinetic Parameters | Multiple Sclerosis | Drug: Prolonged-release Fampridine;Drug: Placebo | University of Zurich | NULL | Active, not recruiting | 18 Years | 65 Years | Both | 70 | Phase 2 | Switzerland |
| 36 | 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 | |||
| 37 | EUCTR2011-006151-10-DK (EUCTR) | 15/02/2012 | 15/02/2012 | FAME - a study of the effect of Fampyra on muscle strength in the lower extremities, walking capacity, coordination in the upper extremitties and cognition in multiple sclerosis patients. | FAME - Fampyra outcome measures study: a study of responsiveness of different outcome measures to Fampyra treatment. - FAME | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE | Sønderjylland Hospital, department of neurology | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 38 | 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 | |||
| 39 | 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 |
| 40 | 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 | ||
| 41 | 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 | ||
| 42 | 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 | |||
| 43 | 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 | |||
| 44 | 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 |
| 45 | NCT01235221 (ClinicalTrials.gov) | December 2010 | 4/11/2010 | Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials. | Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials | Multiple Sclerosis | Drug: BIIB041 (Fampridine-SR) | Biogen Idec | Acorda Therapeutics | Completed | 18 Years | 70 Years | Both | 38 | Phase 3 | Canada |
| 46 | NCT00649792 (ClinicalTrials.gov) | August 2007 | 28/3/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial | Multiple Sclerosis | Drug: Fampridine-SR | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 214 | Phase 3 | United States;Canada |
| 47 | 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 |
| 48 | NCT00648908 (ClinicalTrials.gov) | June 2006 | 28/3/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial | Multiple Sclerosis | Drug: Fampridine-SR | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 269 | Phase 3 | United States;Canada |
| 49 | NCT00127530 (ClinicalTrials.gov) | May 2005 | 4/8/2005 | Study of Oral Fampridine-SR in Multiple Sclerosis | Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine-SR;Drug: Placebo | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 300 | Phase 3 | United States;Canada |
| 50 | NCT00654927 (ClinicalTrials.gov) | November 2003 | 4/4/2008 | Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Fampridine-SR b.i.d. (Twice Daily) | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 177 | Phase 3 | United States;Canada |
| 51 | 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 |