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

NCT03428360 PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	Aquestive Therapeutics
Phase	PHASE3
Status	COMPLETED
Enrolment	149
Start date	Tue Jan 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Jun 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Epilepsy

Interventions

• Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category

Countries

United States