drugset / Trial / NCT05163314

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

NCT05163314

Phase 3 Terminated 352 enrolled Takeda
NaSingle-groupOpen-labelTreatment

Summary

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

Timeline

Start
2022-03-04
Primary completion
2025-09-24
Completion
2025-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Soticlestat Small molecule 100 mg Oral
Subject Soticlestat Small molecule 200 mg Oral
Subject Soticlestat Small molecule 300 mg Oral