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

Summary

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS. Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it. Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.

Timeline

Start

2021-10-28

Primary completion

2024-04-11

Completion

2024-04-11

Drugs

Indications