3. 脊髄性筋萎縮症 Spinal muscular atrophy Clinical trials / Disease details
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. | 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 | EUCTR2015-001589-25-NL (EUCTR) | 05/04/2016 | 07/10/2015 | A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular Atrophy | Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Olesoxime Product Code: RO7090919 INN or Proposed INN: OLESOXIME INN or Proposed INN: SESAME OIL, REFINED Other descriptive name: SESAME OIL, REFINED | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 173 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Germany;Netherlands;Italy;United Kingdom | ||
| 2 | EUCTR2015-001589-25-FR (EUCTR) | 01/12/2015 | 07/12/2015 | A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular Atrophy | Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA | Spinal Muscular Atrophy MedDRA version: 18.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Olesoxime Product Code: RO7090919 INN or Proposed INN: OLESOXIME INN or Proposed INN: SESAME OIL, REFINED Other descriptive name: SESAME OIL, REFINED | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 173 | Phase 2;Phase 3 | France;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2015-001589-25-BE (EUCTR) | 20/11/2015 | 25/09/2015 | A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular Atrophy | Multicenter, open-label, single-arm study to evaluate long term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Olesoxime Product Code: RO7090919 INN or Proposed INN: OLESOXIME INN or Proposed INN: SESAME OIL, REFINED Other descriptive name: SESAME OIL, REFINED | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 173 | Phase 2;Phase 3 | France;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2015-001589-25-GB (EUCTR) | 19/11/2015 | 04/08/2015 | A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular Atrophy | Multicenter, open-label, single-arm study to evaluate long term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Olesoxime Product Code: RO7090919 INN or Proposed INN: OLESOXIME INN or Proposed INN: SESAME OIL, REFINED Other descriptive name: SESAME OIL, REFINED | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 173 | Phase 2;Phase 3 | France;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2015-001589-25-IT (EUCTR) | 05/10/2015 | 11/08/2015 | Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA | Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA | Spinal Muscular Atrophy MedDRA version: 18.0;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Olesoxime Product Code: RO7090919 INN or Proposed INN: OLESOXIME INN or Proposed INN: SESAME OIL, REFINED Other descriptive name: SESAME OIL, REFINED | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 173 | Phase 2;Phase 3 | France;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2015-001589-25-PL (EUCTR) | 07/01/2016 | A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients with Spinal Muscular Atrophy | Multicenter, open-label, single-arm study to evaluate long term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS | Spinal Muscular Atrophy MedDRA version: 20.1;Level: LLT;Classification code 10051203;Term: Spinal muscular atrophy congenital;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Olesoxime Product Code: RO7090919 INN or Proposed INN: OLESOXIME INN or Proposed INN: SESAME OIL, REFINED Other descriptive name: SESAME OIL, REFINED | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 173 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Poland;Netherlands;Germany;Italy;United Kingdom |