drugset / Trial / NCT03428360
Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2018-01-23
- Primary completion
- 2020-06-25
- Completion
- 2020-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diazepam | Small molecule | 5 mg | Other |
| Subject | Diazepam | Small molecule | 7.5 mg | Other |
| Subject | Diazepam | Small molecule | 10 mg | Other |
| Subject | Diazepam | Small molecule | 12.5 mg | Other |
| Subject | Diazepam | Small molecule | 15 mg | Other |
| Subject | Diazepam | Small molecule | 17.5 mg | Other |