At a glance
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)
In Brief
A Phase 3 clinical trial evaluating Soticlestat and Placebo for Dravet Syndrome (DS). Completed, enrolled 144 participants across 66 sites in 18 countries.
Detailed 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.
Study Details
Timeline
Interventions
Soticlestat mini-tablets or tablets.
Soticlestat placebo-matching mini-tablets or tablets.