Dravet Syndrome Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo- Controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Dravet Syndrome
This Phase 3 study will enroll participants diagnosed with Dravet Syndrome (DS) who are still
experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components
(FSMC) per week, despite ongoing treatment with up to three antiepileptic drugs (AEDs), and
meet the other inclusion/exclusion criteria.
Following a 28-day baseline period, participants will begin an 84-day treatment period.
Participants will be assigned to receive twice-daily doses of placebo or cannabidiol oral
solution at the highest dose determined to be safe in a previous trial.
Following study completion, all participants will be invited to receive Cannabidiol Oral
Solution in an open label extension study (under a separate protocol).
n/a
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