11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
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 | 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 | ||
| 3 | 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 |