149
Participants
Start Date
January 23, 2018
Primary Completion Date
June 25, 2020
Study Completion Date
June 25, 2020
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.
Hospital of the University of Pennsylvania, Philadelphia
OnSite Clinical Solutions LLC, Charlotte
Austin Epilepsy Care Center, Austin
Consultants in Epilepsy and Neurology, PLLC, Boise
Hawaii Neuroscience Center, Honolulu
Clinical Research Center of New Jersey (CRCNJ), Voorhees Township
Lead Sponsor
Collaborators (2)
Syneos Health
OTHER
Covance
INDUSTRY
Aquestive Therapeutics
INDUSTRY