Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 120
Summary
- Conditions
- Epilepsy
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The study population was male or female pediatric, adolescent, and adult subjects with a clinical diagnosis of epilepsy and with bouts of increased seizure activity, frequent breakthrough seizures, seizure clusters, or cluster seizures and who were on chronic, intermittent use of rescue medication (eg, Diastat AcuDial or other benzodiazepine).Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 2 years and 65 years
- Gender
- Both males and females
Description
The Primary objective of the study is to assess the safety and tolerability of DBF (study drug) administered a minimum of 3 times to subjects with epilepsy for the treatment of seizures over a minimum 6-month period. Secondary objectives: To evaluate the usability of study drug as assessed by the ab...
The Primary objective of the study is to assess the safety and tolerability of DBF (study drug) administered a minimum of 3 times to subjects with epilepsy for the treatment of seizures over a minimum 6-month period. Secondary objectives: To evaluate the usability of study drug as assessed by the ability of caregivers/subjects to administer study drug based on the Instructions for Use (IFU). To evaluate the Quality of Life (QoL) of the subjects during the study drug treatment period as assessed by use of age-appropriate epilepsy scales over a minimum 6-month period.
Tracking Information
- NCT #
- NCT03428360
- Collaborators
- Syneos Health
- Covance
- Investigators
- Study Director: Gary Slatko Aquestive Therapeutics
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