Procedure: sham procedure (DrugBank: -)
1 disease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 | 3 |
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 | NCT02462759 (ClinicalTrials.gov) | August 19, 2015 | 14/5/2015 | A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA). | A Phase 2, Randomized, Double-blind, Sham-procedure Controlled Study to Assess the Safety and Tolerability and Explore the Efficacy of ISIS 396443 (BIIB058) Administered Intrathecally in Subjects With Spinal Muscular Atrophy Who Are Not Eligible to Participate in the Clinical Studies ISIS 396443-CS3B or ISIS 396443-CS4 | Spinal Muscular Atrophy | Drug: Nusinersen;Procedure: Sham Procedure | Biogen | NULL | Terminated | N/A | N/A | All | 21 | Phase 2 | United States;Germany |
2 | NCT02292537 (ClinicalTrials.gov) | November 24, 2014 | 12/11/2014 | A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA) | A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Later-onset Spinal Muscular Atrophy | Spinal Muscular Atrophy | Drug: Nusinersen;Procedure: Sham procedure | Biogen | NULL | Completed | 2 Years | 12 Years | All | 126 | Phase 3 | United States;Canada;France;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Spain;Sweden;United Kingdom |
3 | NCT02193074 (ClinicalTrials.gov) | August 19, 2014 | 14/7/2014 | A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy | A Phase 3, Randomized, Double-Blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Infantile-onset Spinal Muscular Atrophy | Spinal Muscular Atrophy | Drug: nusinersen;Procedure: Sham procedure | Biogen | NULL | Terminated | N/A | 210 Days | All | 122 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Spain;Sweden;Turkey;United Kingdom;Hong Kong;Taiwan |