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

PHASE3CompletedINTERVENTIONAL
Enrollment

149

Participants

Timeline

Start Date

January 23, 2018

Primary Completion Date

June 25, 2020

Study Completion Date

June 25, 2020

Conditions
Epilepsy
Interventions
DRUG

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

The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff.

Trial Locations (6)

19104

Hospital of the University of Pennsylvania, Philadelphia

28203

OnSite Clinical Solutions LLC, Charlotte

78758

Austin Epilepsy Care Center, Austin

83702

Consultants in Epilepsy and Neurology, PLLC, Boise

96187

Hawaii Neuroscience Center, Honolulu

08043

Clinical Research Center of New Jersey (CRCNJ), Voorhees Township

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Syneos Health

OTHER

collaborator

Covance

INDUSTRY

lead

Aquestive Therapeutics

INDUSTRY