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	4
12	先天性筋無力症候群	1

3. 脊髄性筋萎縮症

臨床試験数 : 237 / 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03819660 (ClinicalTrials.gov)	March 7, 2019	23/1/2019	Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3	Long Term Safety Study of Amifampridine Phosphate in Ambulatory Patients With Spinal Muscular Atrophy (SMA) Type 3	Muscle Atrophy	Drug: Amifampridine Phosphate 10 MG Oral Tablet	Catalyst Pharmaceuticals, Inc.	NULL	Enrolling by invitation	6 Years	50 Years	All	12	Phase 2	Italy
2	NCT03781479 (ClinicalTrials.gov)	January 21, 2019	18/12/2018	Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients	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	Muscular Atrophy, Spinal	Drug: Amifampridine Phosphate;Drug: Placebo Oral Tablet	Catalyst Pharmaceuticals, Inc.	NULL	Completed	6 Years	50 Years	All	13	Phase 2	Italy
3	EUCTR2018-000160-28-IT (EUCTR)	06/11/2018	24/05/2021	Clinical study evaluating the long term safety of amifampridine phosphate in ambulatory patients with Spinal Muscular Atrophy (SMA) type 3	Long 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.	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	Italy
4	EUCTR2017-004600-22-IT (EUCTR)	04/04/2018	07/04/2021	Clinical 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.	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	Italy

11. 重症筋無力症

臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2017-004777-14-IT (EUCTR)	05/06/2018	21/01/2021	Clinical study evaluating the long term safety of amifampridine phosphate in patients with MuSK antibody and AChR antibody positive myasthenia gravis	Long 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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	United States;Canada;Italy
2	NCT03304054 (ClinicalTrials.gov)	March 7, 2018	28/9/2017	Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG	A 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 Patients	Myasthenia Gravis, Generalized	Drug: Amifampridine Phosphate;Drug: Placebo Oral Tablet	Catalyst Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	70	Phase 3	United States
3	EUCTR2017-004018-25-IT (EUCTR)	22/02/2018	19/01/2021	Clinical 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.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Canada;Italy
4	EUCTR2015-003127-62-IT (EUCTR)	02/10/2015	17/03/2017	A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia Gravis	A 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 BESTA	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Italy

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.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02189720 (ClinicalTrials.gov)	July 2014	5/7/2014	Expanded 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 Syndrome	Drug: Amifampridine Phosphate	Catalyst Pharmaceuticals, Inc.	NULL	No longer available	2 Years	N/A	All			United States

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