A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome
Summary
The aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.
Timeline
- Start
- 2021-11-08
- Primary completion
- 2024-01-25
- Completion
- 2024-01-25
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Soticlestat; p =0.785; Hodges-Lehmann Location Shift Estimate -1.17 (95% CI -13.02 to 9.99); ANCOVA NCT04938427 ↗
registry analysis (superiority test); Placebo vs Soticlestat; p =0.778; Hodges-Lehmann Location Shift Estimate 2.43 (95% CI -10.86 to 15.14); ANCOVA NCT04938427 ↗
release “SKYWAY Study in Lennox-Gastaut Syndrome Missed its Primary Endpoint of Reduction in Major Motor Drop Seizures” takeda.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Soticlestat | Small molecule | 40 mg | Oral |
| Subject | Soticlestat | Small molecule | 200 mg | Oral |
| Subject | Soticlestat | Small molecule | 300 mg | Oral |