Overview

Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy

Status:
Completed
Trial end date:
2020-06-25
Target enrollment:
Participant gender:
Summary
This Phase 3, multicenter, open-label study of chronic, intermittent use of study drug (DBF) is designed to evaluate the safety and tolerability of the buccal formulation of diazepam in children, adolescents and adults with intermittent, stereotypic episodes of frequent seizure activity (eg, seizure clusters) that are distinct from the subject's usual seizure pattern.
Phase:
Phase 3
Details
Lead Sponsor:
Aquestive Therapeutics
Collaborators:
Covance
Inventiv Health
Syneos Health
Treatments:
Diazepam