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

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 31, 2017

Primary Completion Date

January 28, 2020

Study Completion Date

March 11, 2020

Conditions
Epilepsy
Interventions
DRUG

Diazepam Buccal Film

Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses.

Trial Locations (10)

10029

Icahn School of Medicine at Mount Sinai, New York

14607

University of Rochester, Rochester

19104

Children's Hospital of Philadelphia, Philadelphia

23298

Virginia Commonwealth University, Richmond

28203

Onsite Clinical Solutions LLC, Charlotte

32561

NW FL Clinical Research Group, LLC, Gulf Breeze

78723

Dell Children's Medical Center, Austin

78758

Austin Epilepsy Care Center, Austin

85719

University of Arizona, Tucson

08901

Children's St. Peters University Hospital, New Brunswick

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Syneos Health

OTHER

collaborator

Covance

INDUSTRY

lead

Aquestive Therapeutics

INDUSTRY

NCT03222349 - Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy | Biotech Hunter | Biotech Hunter