drugset / Trial / NCT03635073

A Study of Soticlestat in Adults and Children With Rare Epilepsies

NCT03635073 ↗

Phase 2 Terminated 156 enrolled Takeda
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

EvaluationDrugModalityDoseRoute
Subject Soticlestat Small molecule — Oral