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 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

  
24 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2013-003600-40-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
2EUCTR2013-003600-40-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
3EUCTR2013-003600-40-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
4EUCTR2013-003600-40-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
5EUCTR2013-003600-40-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
6EUCTR2013-003600-40-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;Finland;Poland;Lithuania;Russian Federation;Bulgaria;Netherlands;Italy;United Kingdom;Switzerland
7NCT02219932
(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
8EUCTR2013-003600-40-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
9NCT01917019
(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
10EUCTR2012-005076-34-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, NeurologieNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Belgium
11EUCTR2012-000368-90-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
12EUCTR2012-000368-90-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
13NCT01597297
(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
14EUCTR2012-000368-90-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
15EUCTR2012-000368-90-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
16NCT01480063
(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
17EUCTR2011-003507-38-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
18EUCTR2011-003507-38-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
19NCT01480076
(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
20EUCTR2011-003507-38-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
21EUCTR2011-003507-38-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
22EUCTR2011-003507-38-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
23EUCTR2011-003507-38-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
24NCT01235221
(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