Fampyra ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica32
14Chronic inflammatory demyelinating polyneuropathy1

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,342 Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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
2EUCTR2014-004650-34-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
3EUCTR2014-003498-41-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
4EUCTR2013-003600-40-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
5EUCTR2015-000182-31-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
6EUCTR2013-003600-40-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
7EUCTR2013-003600-40-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
8EUCTR2013-003600-40-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
9EUCTR2013-003600-40-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
10EUCTR2013-003600-40-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
11EUCTR2013-003600-40-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
12EUCTR2013-002558-64-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
13EUCTR2013-000529-30-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
14EUCTR2013-001409-10-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
15EUCTR2011-002959-34-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
16EUCTR2012-005076-34-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
17NCT01720849
(ClinicalTrials.gov)
December 201231/10/2012Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple SclerosisMultiple Sclerosis;EDSS 4-7Drug: FampyraVestre Viken Hospital TrustNULLRecruiting18 YearsN/ABoth50N/ANorway
18EUCTR2012-000368-90-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
19EUCTR2012-000368-90-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
20EUCTR2012-000368-90-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
21EUCTR2012-000368-90-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
22NCT01656148
(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
23EUCTR2012-000287-17-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
24NCT01480063
(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
25EUCTR2011-002561-38-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
26EUCTR2011-003507-38-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
27EUCTR2011-006151-10-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
28EUCTR2011-003507-38-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
29EUCTR2011-003507-38-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
30EUCTR2011-003507-38-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
31EUCTR2011-003507-38-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
32EUCTR2011-003507-38-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

14. Chronic inflammatory demyelinating polyneuropathy


Clinical trials : 167 Drugs : 158 - (DrugBank : 38) / Drug target genes : 13 - Drug target pathways : 23
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002438-34-DK
(EUCTR)
19/08/202011/06/2020Fampridine for treatment of functional disability in patients with immune mediated polyneuropathyFampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy Chronic inflammatory demyelinating polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10072650;Term: CIDP;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Fampyra
Product Name: Fampyra
INN or Proposed INN: FAMPRIDINE
Department of Neurology, Odense University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Denmark