A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome
About this clinical trial
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.
At a glance
What medical conditions were being studied?
What was the clinical trial testing?
Placebo, Soticlestat
How many participants were enrolled?
270
Were placebos part of the clinical trial?
Yes
When was the clinical trial conducted?
Nov 2021 - Jan 2024
How long was participation in the clinical trial?
Participants will be in this study for about 25 weeks.
Key requirements
Sexes
All
Age
2-55 years
Healthy volunteers?
No