drugset / Trial / NCT05128344
A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).
Timeline
- Start
- 2023-04
- Primary completion
- 2025-06
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMZ002 | Unknown | 0.5 mg/ml | Other |
| Comparator | Vigabatrin | Small molecule | — | Oral |