drugset / Trial / NCT04938427

A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome

NCT04938427

Phase 3 Completed 270 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Soticlestat Small molecule 40 mg Oral
Subject Soticlestat Small molecule 200 mg Oral
Subject Soticlestat Small molecule 300 mg Oral