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 : 2,380 - (DrugBank : 407) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240

  
61 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2021-003677-66-NL
(EUCTR)
14/02/202216/12/2021Clemastine fumarate as a treament for eye movement disorders in patients with multiple sclerosisClemastine 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 CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 3Netherlands
2NCT03847545
(ClinicalTrials.gov)
December 12, 201819/12/2018Muscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle Tracking TechniqueMuscle Strain in Multiple Sclerosis Patients Measured by Ultrasound Speckle TrackingMultiple SclerosisDrug: FampridineUniversity of Southern DenmarkOdense 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 forskningsfondRecruiting18 Years100 YearsAll60N/ADenmark
3NCT03164018
(ClinicalTrials.gov)
March 7, 201729/3/2017Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life AnalysisFampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life AnalysisMultiple SclerosisDrug: FampridineGenesis Pharma CNS & SpecialtyNULLCompleted18 YearsN/AAll111Greece
4EUCTR2014-004650-34-IT
(EUCTR)
27/06/201605/11/2020New strategies for diagnostic, therapeutic and clinical care in neurological diseasesNeuromodulation 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. MONDINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 4Italy
5EUCTR2014-003498-41-AT
(EUCTR)
22/09/201506/08/2015Effects of dalfampridine on mobility in the context of daily lifeEffects 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 ViennaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
6NCT01532154
(ClinicalTrials.gov)
August 201515/12/2011Fampridine Pregnancy Exposure RegistryFampridine Pregnancy Exposure RegistryMultiple Sclerosis;PregnancyDrug: FampridineBiogenNULLTerminatedN/AN/AFemale1N/AFrance;Germany;United Kingdom;United States
7NCT02391961
(ClinicalTrials.gov)
April 1, 20153/3/2015Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple SclerosisStudy and Treatment of Visual Dysfunction and Motor Fatigue in Multiple SclerosisMultiple Sclerosis;Internuclear Ophthalmoplegia;FatigueDrug: Dalfampridine;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years65 YearsAll23Phase 2United States
8EUCTR2013-003600-40-NL
(EUCTR)
20/02/201526/11/2014Study 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
590Phase 3Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland
9EUCTR2015-000182-31-NL
(EUCTR)
11/02/201526/01/2015Study to evaluate the effects of fampridine in patients with multiple sclerosis and eye movement abnormalityA 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
CHDRNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
10EUCTR2013-003600-40-BG
(EUCTR)
04/12/201417/10/2014Study 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
590Phase 3Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland
11NCT02259361
(ClinicalTrials.gov)
November 20141/10/2014Efficacy of Dalfampridine on Upper Extremity Function in Patients With MSEfficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot StudyMultiple SclerosisDrug: Sustained-release oral dalfampridine;Drug: PlaceboSheba Medical CenterNULLNot yet recruiting18 Years70 YearsBoth30Phase 4Israel
12EUCTR2013-003600-40-CZ
(EUCTR)
22/10/201419/06/2014Study 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
590Phase 3United States;Serbia;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;United Kingdom;Switzerland;Italy
13NCT02280096
(ClinicalTrials.gov)
October 201410/10/2014Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple SclerosisEfficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis. Randomized, Blinded, Placebo-controlled Clinical Trial.Multiple SclerosisDrug: 4-aminopyridine;Drug: PlaceboCoordinación de Investigación en Salud, MexicoNULLCompleted18 Years60 YearsAll24Phase 2Mexico
14EUCTR2013-003600-40-GB
(EUCTR)
15/09/201408/05/2014Study 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
590Phase 3United States;Serbia;Finland;Ukraine;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Poland;Bulgaria;Netherlands
15EUCTR2013-003600-40-IT
(EUCTR)
11/09/201427/06/2014Study 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
590Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;United Kingdom;Switzerland;Italy
16EUCTR2013-003600-40-LT
(EUCTR)
02/09/201418/06/2014Study 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
590Serbia;United States;Czech Republic;Switzerland;United Kingdom;Italy;Netherlands;Bulgaria;Russian Federation;Lithuania;Poland;Finland
17NCT02219932
(ClinicalTrials.gov)
September 201418/8/2014Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple SclerosisA 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 SclerosisDrug: fampridine;Drug: PlaceboBiogenNULLCompleted18 Years70 YearsAll646Phase 3United States;Bulgaria;Czech Republic;Finland;Italy;Lithuania;Netherlands;Poland;Russian Federation;Serbia;United Kingdom;Argentina;Germany;Switzerland
18EUCTR2013-003600-40-FI
(EUCTR)
05/08/201421/07/2014Study 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
590Serbia;United States;Czech Republic;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland
19NCT02143167
(ClinicalTrials.gov)
May 20149/5/2014Resistance Training and Amino Pyridine in Multiple SclerosisRETRAP - A Double Blind, Randomized, Placebo Controlled Study of the Effect of the Combination of Resistance Training and Prolonged Release Fampridine in Patients With Multiple SclerosisMultiple SclerosisDrug: SR-fampridine;Drug: PlaceboUniversity of Southern DenmarkRegion of Southern Denmark;BiogenCompleted18 Years60 YearsAll40Phase 4Denmark
20NCT02208050
(ClinicalTrials.gov)
February 21, 201419/5/2014A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MSA Phase IV Double Blind, Randomized, Placebo Controlled, Crossover Study of the Effectiveness of Oral Fampridine in Improving Upper Limb Function in Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Fampridine;Drug: PlaceboUniversity College DublinNULLCompleted18 Years70 YearsAll64Phase 4Ireland
21NCT02849782
(ClinicalTrials.gov)
February 4, 201422/7/2016Short 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 PerformancesMultiple SclerosisDrug: FampridineCentre Hospitalier Universitaire de BesanconNULLCompleted18 Years80 YearsAll89Phase 4France
22NCT02166346
(ClinicalTrials.gov)
February 201416/6/2014Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis (Re-Launch)Double-Blind, Placebo-Controlled Crossover Trial on the Safety and Efficacy of Sustained-Release Dalfampridine in Transverse Myelitis (Re-Launch)Transverse Myelitis;Neuromyelitis Optica;Idiopathic Transverse Myelitis;Myelitis NOSDrug: Dalfampridine;Drug: PlaceboJohns Hopkins UniversityAcorda TherapeuticsCompleted18 Years70 YearsAll24Phase 2United States
23EUCTR2013-002558-64-IT
(EUCTR)
18/12/201316/10/2013improvement of cognitive performance after administration of fampridina in patients with multiple sclerosisA 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 psichiatriaNULLNot RecruitingFemale: yes
Male: yes
123Phase 4Italy
24NCT02146534
(ClinicalTrials.gov)
December 201323/4/2014Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS PatientsProlonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: a Phase IV, Double-blind, Placebo-controlled Study.Multiple SclerosisDrug: extended release fampridine;Drug: PlaceboClinique Neuro-OutaouaisCogState Ltd.Completed18 YearsN/AAll44Phase 4Canada
25EUCTR2013-000529-30-GB
(EUCTR)
27/11/201317/10/2013prolonged-release oral fampridine in Neuromyelitis Optica (NMO), Pilot feasibility StudyA 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 TrustNULLNot 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): yesUnited Kingdom
26EUCTR2013-001409-10-DK
(EUCTR)
08/08/201306/08/2013Fampyra and T cell Immunity in Multiple Sclerosis; a study of the Fampyra induced immunomodulatory T cell responses in MSFATIMS - 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Denmark
27NCT01917019
(ClinicalTrials.gov)
August 20132/8/2013A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple SclerosisA 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 ExtensionMultiple Sclerosis, Remittent Progressive;Multiple Sclerosis, Primary Progressive;Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Multiple SclerosisDrug: Placebo;Drug: BIIB041 (fampridine)BiogenNULLCompleted18 Years70 YearsAll101Phase 3Japan
28EUCTR2011-002959-34-DK
(EUCTR)
11/03/201301/03/2013RETRAP - 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 neurologyNULLNot RecruitingFemale: yes
Male: yes
125Phase 4Denmark
29EUCTR2012-005076-34-BE
(EUCTR)
03/01/201314/12/2012Prolonged-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, NeurologieNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
30EUCTR2012-000368-90-NL
(EUCTR)
02/10/201206/08/2012Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple SclerosisA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
120Canada;Belgium;Netherlands;United Kingdom;Italy;Sweden
31NCT01667497
(ClinicalTrials.gov)
September 201213/8/2012Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients?Does Fampridine SR Improve Cognitive Fatigue in Multiple Sclerosis Patients? A Cross Over StudyCognitive FatigueDrug: Fampridine SR;Drug: PlaceboLondon Health Sciences CentreNULLCompleted18 Years64 YearsBoth60Phase 2/Phase 3Canada
32EUCTR2012-000368-90-BE
(EUCTR)
08/08/201211/06/2012Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple SclerosisA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Canada;Belgium;Netherlands;Italy;United Kingdom;Sweden
33NCT01597297
(ClinicalTrials.gov)
August 201210/5/2012Exploratory 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 SclerosisMultiple SclerosisDrug: BIIB041 (PR Fampridine);Other: PlaceboBiogenNULLCompleted18 Years70 YearsAll132Phase 2Belgium;Canada;Italy;Netherlands;Sweden;United Kingdom
34EUCTR2012-000368-90-IT
(EUCTR)
30/07/201212/09/2012Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple SclerosisA 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 LTDNULLNot RecruitingFemale: yes
Male: yes
120Canada;Belgium;Netherlands;United Kingdom;Switzerland;Italy
35EUCTR2012-000368-90-GB
(EUCTR)
27/06/201210/07/2012Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple SclerosisA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
120Canada;Belgium;Netherlands;Italy;United Kingdom;Sweden
36NCT01656148
(ClinicalTrials.gov)
June 201231/7/2012FAME - Fampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of FampyraFampyra Outcome Measures Study: a Study of Different Outcome Measures on the Effect of FampyraMultiple SclerosisDrug: Fampridine-SRUniversity of Southern DenmarkRegion of Southern Denmark;BiogenCompleted18 Years60 YearsAll108Phase 4Denmark
37EUCTR2012-000287-17-IT
(EUCTR)
21/05/201218/06/2012functional MRI study to evaluate improvement of hand performance after combined motor exercise and aminopiridine assumptionPROMOTION 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 LUCIANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
38NCT01480063
(ClinicalTrials.gov)
April 16, 201223/11/2011An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical PracticeA 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 SclerosisDrug: FampridineBiogenNULLCompletedN/AN/AAll4734Argentina;Canada;Czechia;France;Germany;Ireland;Israel;Lebanon;Netherlands;Norway;Portugal;Spain;United Arab Emirates;Australia;Belgium;Czech Republic;Denmark
39EUCTR2011-002561-38-IE
(EUCTR)
30/03/201209/02/2012Trial 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 HospitalNULLNot RecruitingFemale: yes
Male: yes
80Phase 4Ireland
40NCT01576354
(ClinicalTrials.gov)
March 201222/3/2012Characterization of the Effects of Prolonged-release Fampridine on Ambulatory Function in Patients With Multiple SclerosisA 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 ParametersMultiple SclerosisDrug: Prolonged-release Fampridine;Drug: PlaceboUniversity of ZurichNULLActive, not recruiting18 Years65 YearsBoth70Phase 2Switzerland
41EUCTR2011-003507-38-IT
(EUCTR)
22/02/201202/03/2012Long-Term Prolonged-Release Fampridine Treatment and Quality of LifeAn 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 LTDNULLNot RecruitingFemale: yes
Male: yes
800Portugal;Denmark;Australia;Netherlands;United Kingdom;Italy
42EUCTR2011-006151-10-DK
(EUCTR)
15/02/201215/02/2012FAME - 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 neurologyNULLNot RecruitingFemale: yes
Male: yes
Denmark
43EUCTR2011-003507-38-PT
(EUCTR)
03/02/201228/11/2011Long-Term Prolonged-Release Fampridine Treatment and Quality of LifeAn 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
800France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
44NCT01480076
(ClinicalTrials.gov)
February 201223/11/2011Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple SclerosisAn 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 SclerosisMultiple SclerosisDrug: FampridineBiogenNULLCompleted18 Years75 YearsAll901Phase 4Australia;Belgium;Denmark;France;Germany;Italy;Netherlands;Portugal;United Kingdom;United States
45EUCTR2011-003507-38-BE
(EUCTR)
23/01/201204/11/2011Long-Term Prolonged-Release Fampridine Treatment and Quality of LifeAn 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
800Phase 4France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
46EUCTR2011-003507-38-GB
(EUCTR)
06/01/201220/10/2011Long-Term Prolonged-Release Fampridine Treatment and Quality of LifeAn 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
800Phase 4United Kingdom;Sweden;France;Portugal;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy
47EUCTR2011-003507-38-NL
(EUCTR)
05/01/201207/11/2011Long-Term Prolonged-Release Fampridine Treatment and Quality of LifeAn 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
800France;Portugal;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
48EUCTR2011-003507-38-DK
(EUCTR)
05/01/201205/12/2011Long-Term Prolonged-Release Fampridine Treatment and Quality of LifeAn 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
800France;Portugal;Belgium;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
49NCT01535664
(ClinicalTrials.gov)
January 20127/2/2012An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MSMultiple SclerosisOther: Withdrawal of dalfampridine-ER 10mgAcorda TherapeuticsPrometrika, LLC;BCS Consulting, Inc.Completed18 Years70 YearsAll20United States
50NCT02006160
(ClinicalTrials.gov)
December 20116/6/2012Effects of Dalfampridine on Cognition in Multiple SclerosisEffects of Dalfampridine on Cognition in Multiple SclerosisMultiple SclerosisDrug: dalfampridine;Drug: placeboState University of New York at BuffaloNULLCompleted18 Years60 YearsAll61Phase 2/Phase 3United States
51NCT01444300
(ClinicalTrials.gov)
September 201120/9/2011Dalfampridine for Imbalance in Multiple SclerosisDalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot StudyMultiple Sclerosis;FatigueDrug: Dalfampridine;Drug: PlaceboOregon Health and Science UniversityAcorda TherapeuticsCompleted20 Years59 YearsAll24Phase 2United States
52NCT01337986
(ClinicalTrials.gov)
May 201113/4/2011Ampyra for Optic Neuritis in Multiple SclerosisDalfampridine After Optic Neuritis to Improve Visual Function in Multiple SclerosisMultiple Sclerosis;Optic NeuritisDrug: Dalfampridine/Placebo;Drug: Placebo/DalfampridineWashington University School of MedicineAcorda TherapeuticsCompleted18 Years55 YearsAll53Phase 2/Phase 3United States
53NCT01328379
(ClinicalTrials.gov)
March 201129/3/2011Study of Fampridine-ER Tablets in Patients With Multiple SclerosisDouble-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 SclerosisMultiple SclerosisDrug: Dalfampridine-ER 5mg;Drug: Dalfampridine-ER 10mg;Other: PlaceboAcorda TherapeuticsNULLCompleted18 Years70 YearsAll430Phase 3United States
54NCT01235221
(ClinicalTrials.gov)
December 20104/11/2010Open 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 TrialsMultiple SclerosisDrug: BIIB041 (Fampridine-SR)Biogen IdecAcorda TherapeuticsCompleted18 Years70 YearsBoth38Phase 3Canada
55NCT01356940
(ClinicalTrials.gov)
November 201018/5/2011A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple SclerosisA Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple SclerosisMultiple SclerosisDrug: dalfampridine ER;Drug: placeboBrown, Theodore R., M.D., MPHAcorda TherapeuticsCompleted18 Years75 YearsAll43Phase 4United States
56NCT00649792
(ClinicalTrials.gov)
August 200728/3/2008Open-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 TrialPhase 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 TrialMultiple SclerosisDrug: Fampridine-SRAcorda TherapeuticsNULLCompleted18 Years70 YearsAll214Phase 3United States;Canada
57NCT00483652
(ClinicalTrials.gov)
May 20076/6/2007Study of Fampridine-SR Tablets in Multiple Sclerosis PatientsDouble-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 SclerosisMultiple SclerosisDrug: Fampridine-SR;Drug: PlaceboAcorda TherapeuticsNULLCompleted18 Years70 YearsAll240Phase 3United States;Canada
58NCT00648908
(ClinicalTrials.gov)
June 200628/3/2008Open-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 TrialPhase 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 TrialMultiple SclerosisDrug: Fampridine-SRAcorda TherapeuticsNULLCompleted18 Years70 YearsAll269Phase 3United States;Canada
59NCT00127530
(ClinicalTrials.gov)
May 20054/8/2005Study of Oral Fampridine-SR in Multiple SclerosisDouble-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple SclerosisMultiple SclerosisDrug: Fampridine-SR;Drug: PlaceboAcorda TherapeuticsNULLCompleted18 Years70 YearsAll300Phase 3United States;Canada
60NCT00654927
(ClinicalTrials.gov)
November 20034/4/2008Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple SclerosisPhase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple SclerosisMultiple SclerosisDrug: Fampridine-SR b.i.d. (Twice Daily)Acorda TherapeuticsNULLCompleted18 Years70 YearsAll177Phase 3United States;Canada
61NCT00053417
(ClinicalTrials.gov)
February 200329/1/2003Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple SclerosisDouble-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple SclerosisMultiple SclerosisDrug: 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 TherapeuticsNULLCompleted18 Years70 YearsAll206Phase 2United States;Canada