Lennox-Gastaut 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 Lennox-Gastaut Syndrome
This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who
are still experiencing at least 4 motor seizures involving the trunk or extremities per week,
despite ongoing treatment with up to 3 antiepileptic drugs (AEDs) and who meet
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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