Amifampridine ( DrugBank: Amifampridine )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
3脊髄性筋萎縮症4
11重症筋無力症5
12先天性筋無力症候群1

3. 脊髄性筋萎縮症


臨床試験数 : 217 薬物数 : 149 - (DrugBank : 33) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 80
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03819660
(ClinicalTrials.gov)
March 7, 201923/1/2019Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3Long Term Safety Study of Amifampridine Phosphate in Ambulatory Patients With Spinal Muscular Atrophy (SMA) Type 3Muscle AtrophyDrug: Amifampridine Phosphate 10 MG Oral TabletCatalyst Pharmaceuticals, Inc.NULLEnrolling by invitation6 Years50 YearsAll12Phase 2Italy
2NCT03781479
(ClinicalTrials.gov)
January 21, 201918/12/2018Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 PatientsA Randomized, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients With Spinal Muscular Atrophy (SMA) Type 3Muscular Atrophy, SpinalDrug: Amifampridine Phosphate;Drug: Placebo Oral TabletCatalyst Pharmaceuticals, Inc.NULLCompleted6 Years50 YearsAll13Phase 2Italy
3EUCTR2018-000160-28-IT
(EUCTR)
06/11/201824/05/2021Clinical study evaluating the long term safety of amifampridine phosphate in ambulatory patients with Spinal Muscular Atrophy (SMA) type 3Long term safety study of amifampridine phosphate in ambulatory patients with Spinal Muscular Atrophy (SMA) type 3 - SMA-002 Spinal Muscular Atrophy (SMA) Type 3
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: Amifampridina fosfato
Product Code: [Amifampridina fosfato]
INN or Proposed INN: AMIFAMPRIDINA
CATALYST PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
12Phase 2Italy
4EUCTR2017-004600-22-IT
(EUCTR)
04/04/201807/04/2021Clinical study evaluating the effect of Amifampridine Phosphate in Ambulatory Patients with Spinal Muscular Atrophy (SMA) Type 3.A Randomized, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients with Spinal Muscular Atrophy (SMA) Type 3 - SMA-001 Spinal Muscular Atrophy (SMA) Type 3
MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal muscular atrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: Amifampridina fosfato
Product Code: [Amifampridina fosfato]
INN or Proposed INN: AMIFAMPRIDINA
Other descriptive name: 3,4-Diaminopyridine Phosphate
CATALYST PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
12Phase 2Italy

11. 重症筋無力症


臨床試験数 : 315 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03579966
(ClinicalTrials.gov)
July 1, 20185/6/2018Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia GravisMyasthenia Gravis, MuSKDrug: Amifampridine PhosphateCatalyst Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll70Phase 3United States
2EUCTR2017-004777-14-IT
(EUCTR)
05/06/201821/01/2021Clinical study evaluating the long term safety of amifampridine phosphate in patients with MuSK antibody and AChR antibody positive myasthenia gravisLong term safety study of amifampridine phosphate in patients with MuSK antibody positive and AChR antibody positive myasthenia gravis patients - MSK-003 MuSK antibody and AChR antibody positive myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: Amifampridina fosfato
Product Code: [Amifampridina fosfato]
INN or Proposed INN: AMIFAMPRIDINA
CATALYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;Canada;Italy
3NCT03304054
(ClinicalTrials.gov)
March 7, 201828/9/2017Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MGA Randomized, Placebo-control, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients With MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis PatientsMyasthenia Gravis, GeneralizedDrug: Amifampridine Phosphate;Drug: Placebo Oral TabletCatalyst Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll70Phase 3United States
4EUCTR2017-004018-25-IT
(EUCTR)
22/02/201819/01/2021Clinical study evaluating the effect of Amifampridine phosphate in patients with MuSK antibody positive myasthenia gravis, and a sample of AchR antibody positive myasthenia gravis patients A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients with MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients - MSK-002 MuSK antibody positive myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: Amifampridina fosfato
Product Code: [Amifampridina fosfato]
INN or Proposed INN: AMIFAMPRIDINA
CATALYST PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Canada;Italy
5EUCTR2015-003127-62-IT
(EUCTR)
02/10/201517/03/2017A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia GravisA Randomized, Placebo-Controlled, Pilot Crossover Study to Evaluate the Effect of Amifampridine Phosphate(3,4-Diaminopyridine Phosphate) in Patients with MuSK Antibody Positive Myasthenia Gravis - MuSK-001 Patients with MuSK Antibody Positive Myasthenia Gravis
MedDRA version: 19.1;Level: LLT;Classification code 10062976;Term: Neuromuscular weakness;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: AMIFAMPRIDINA
INN or Proposed INN: AMIFAMPRIDINA
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLNot RecruitingFemale: yes
Male: yes
20Phase 2Italy

12. 先天性筋無力症候群


臨床試験数 : 5 薬物数 : 7 - (DrugBank : 3) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 13
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02189720
(ClinicalTrials.gov)
July 20145/7/2014Expanded Access Study Amifampridine Phosphate in Congenital Myasthenic Syndrome (CMS)An Open-Label, Expanded Access Protocol for Amifampridine Phosphate Treatment in Patients With Congenital Myasthenic Syndrome (CMS)Congenital Myasthenic SyndromeDrug: Amifampridine PhosphateCatalyst Pharmaceuticals, Inc.NULLNo longer available2 YearsN/AAllUnited States