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NCT03428360 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
A Phase 3 study, sponsored by Aquestive Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 149
- Enrollment target
NCT03428360: Completed Phase 3 study, sponsored by Aquestive Therapeutics.
NCT03428360 is a Phase 3 study that has completed, run by Aquestive Therapeutics. The registered enrollment target is 149 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03428360, a Phase 3 study, has completed, sponsored by Aquestive Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 149 participants
- Enrollment target
Study 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.
Primary Outcome
A TEAE was defined as any adverse event with onset date on the day of or after administration of study drug including relationship and severity.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2018-01-23 |
| Est. Completion | 2020-06-25 |
| Phase | Phase 3 |
What the finished NCT03428360 record still lists
NCT03428360 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which 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 is the first listed.
NCT03428360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03428360 about?
NCT03428360 is a clinical study titled "Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy". 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...
What is the current status of trial NCT03428360?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 149 participants. The study started on 2018-01-23. Estimated completion is 2020-06-25.
What interventions are being tested in trial NCT03428360?
The interventions under investigation include: 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 (DRUG).
Who is sponsoring clinical trial NCT03428360?
This trial is sponsored by Aquestive Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03428360's enrollment target sits among peer trials
149 1546th of 2000 higher than 454 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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