Lundbeck LLC has initiated the CLOVER I Study to investigate the use of clobazam for the treatment of children and adolescents with Dravet syndrome — a rare and severe form of epilepsy that begins in infancy. The drug already is approved in the U.S. for seizures associated with another epilepsy syndrome.
The study is designed to evaluate clobazam as an adjunctive therapy in pediatric patients aged one to 16 years of age with Dravet syndrome. The primary objective of the study is to investigate the drug’s effect on the frequency of tonic-clonic and clonic seizures after 16 weeks of treatment. The multicenter study will enroll 54 patients in approximately 25 sites in three countries: Argentina, Mexico and the United States.3 At the end of the study, participants may have the option of joining the 52-week CLOVER II study.