A Clinical Research Study for Children Teens and Young Adults Diagnosed With Dravet Syndrome The Skyline Study

Brief description of study

The Skyline Study is a Phase 3 clinical research study of an investigational medication for children, teens, and young adults diagnosed with Dravet syndrome who are currently taking 0 - 4 anti-seizure medications to manage symptoms and are still experiencing seizures. The investigational medication, soticlestat, works differently than currently approved medications and is being tested as an add-on therapy in the clinical research study.

The goal of the Phase 3 clinical research study is to assess the effectiveness, safety and tolerability of the investigational medication when taken with other anti-seizure treatments. In previous clinical research studies, the investigational medication has been shown to reduce the number of seizures in study participants.

During the study, participants will be split into two groups: one will receive the study drug and one will receive placebo (looks like the study drug but contains no active ingredients). After completing the study, participants can join the open-label extension (OLE) study where every participant will receive the study drug.

Clinical Study Identifier: s21-01576

ClinicalTrials.gov Identifier: NCT04940624

Principal Investigator: Orrin Devinsky.

Other Investigators: Erin K Conway, Cassandra Kazl, Ilyse Haberman, Daniel Friedman.

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