drugset / Trial / NCT03635073
A Study of Soticlestat in Adults and Children With Rare Epilepsies
NaSingle-groupOpen-labelTreatment
Summary
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study. Study treatments may continue as long as the participant is receiving benefit from it.
Timeline
- Start
- 2018-07-19
- Primary completion
- 2025-07-30
- Completion
- 2025-07-30
Outcome
Outcome not reported
Stopped: “Due to negative results from phase 3 SKYLINE and SKYWAY studies and unrelated to patient safety it has been determined that supplementary data from TAK-935-18-001 study is no longer necessary. Therefore, Takeda has made a decision to close this study”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Soticlestat | Small molecule | — | Oral |