Prolonged-release Fampridine ( DrugBank: Fampridine )


1 disease
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica17

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,342 Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
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PhaseCountries
1NCT02219932
(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
2NCT02146534
(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
3NCT01917019
(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
4EUCTR2011-002959-34-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
5EUCTR2012-000368-90-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
6EUCTR2012-000368-90-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
7NCT01597297
(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
8EUCTR2012-000368-90-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
9EUCTR2012-000368-90-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
10NCT01576354
(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
11EUCTR2011-003507-38-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
12EUCTR2011-003507-38-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
13NCT01480076
(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
14EUCTR2011-003507-38-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
15EUCTR2011-003507-38-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
16EUCTR2011-003507-38-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
17EUCTR2011-003507-38-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