drugset / Trial / NCT03347526
A Novel Approach to Infantile Spasms
Phase 3
Suspended
394 enrolled
University of Colorado, Denver
Pediatric Epilepsy Research Foundation · collabWest Therapuetics, Inc · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).
Timeline
- Start
- 2018-04-19
- Primary completion
- 2021-06
- Completion
- 2021-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cosyntropin | Unknown | 1 mg/ml | Other |
| Comparator | Vigabatrin | Small molecule | — | Oral |