Phase 3 Trial Initiated to Evaluate Cannabidiol for Individuals with Epilepsy and Myoclonic-Atonic Seizures

A new phase 3 trial (NCT05288283) has been initiated to evaluate cannabidiol for potential treatment of children and adolescents with epilepsy and myoclonic-atonic seizures (EMAS). The study is randomized, double-blind, and placebo-controlled and will measure change from baseline in EMAS-associated seizure frequency with 14 weeks of cannabidiol treatment vs placebo.

Children and adolescents, ages 1 to 18 years, with EMAS are eligible to enroll. After the 14-week double-blind portion of the trial, participants may choose to enroll in a 54-week open-label extension study.

"Given there are numerous treatment-resistant epilepsy syndromes, epileptologists often look for efficacy by seizure type, most of which have no syndrome-specific approved treatment. An EMAS indication would provide support for the use of Epidiolex in a fourth indication of a distinct, generalized seizure type, myoclonic-atonic seizures," said Rob Iannone, MD, MSCE, executive vice president, global head of research and development of Jazz Pharmaceuticals. "Jazz is committed to continuing to generate clinical study data and real-world evidence to further support the utility of the company's cannabidiol across a broad range of difficult-to-treat seizure types."