1. 球脊髄性筋萎縮症 Spinal and bulbar muscular atrophy Clinical trials / Disease details
臨床試験数 : 18 / 薬物数 : 15 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 17
| 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 | EUCTR2013-002608-15-DE (EUCTR) | 15/08/2014 | 15/04/2014 | A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophy | A two-part placebo-controlled study to evaluate the safety, tolerability andpreliminary efficacy of BVS857 in patients with spinal and bulbar muscularatrophy (SBMA) | Spinal and bulbar muscular atrophy (SBMA) MedDRA version: 18.1;Level: PT;Classification code 10068597;Term: Bulbospinal muscular atrophy congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BVS857 INN or Proposed INN: - | Novartis Pharma Services AG | NULL | Not Recruiting | Female: no Male: yes | 38 | Phase 2 | United States;Denmark;Germany;Italy | ||
| 2 | EUCTR2013-002608-15-IT (EUCTR) | 12/06/2014 | 14/02/2014 | A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophy | A two-part placebo-controlled study to evaluate the safety, tolerability andpreliminary efficacy of BVS857 in patients with spinal and bulbar muscularatrophy (SBMA) | Spinal and bulbar muscular atrophy (SBMA) MedDRA version: 16.1;Level: PT;Classification code 10068597;Term: Bulbospinal muscular atrophy congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BVS857 INN or Proposed INN: NA Other descriptive name: NA | Novartis Farma SpA | NULL | Not Recruiting | Female: no Male: yes | 38 | Phase 2 | United States;Denmark;Germany;Italy | ||
| 3 | EUCTR2013-002608-15-DK (EUCTR) | 19/05/2014 | 21/03/2014 | A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophy | A two-part placebo-controlled study to evaluate the safety, tolerability and preliminary efficacy of BVS857 in patients with spinal and bulbar muscular atrophy (SBMA) | Spinal and bulbar muscular atrophy (SBMA) MedDRA version: 18.1;Level: PT;Classification code 10068597;Term: Bulbospinal muscular atrophy congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BVS857 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: no Male: yes | 38 | Phase 2 | United States;Denmark;Germany;Italy | ||
| 4 | NCT02024932 (ClinicalTrials.gov) | February 4, 2014 | 29/12/2013 | Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy | A Two-part Placebo-controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy (SBMA) | Spinal and Bulbar Muscular Atrophy | Drug: BVS857;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Male | 37 | Phase 2 | United States;Denmark;Germany;Italy |