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NCT03179891 · ClinicalTrials.gov registry record · Phase 2
Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
A Phase 2 study, sponsored by Aquestive Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT03179891: Completed Phase 2 study, sponsored by Aquestive Therapeutics.
NCT03179891 is a Phase 2 study that has completed, run by Aquestive Therapeutics. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03179891, a Phase 2 study, has completed, sponsored by Aquestive Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This Phase 2 open-label, two-way study was conducted in adult subjects with epilepsy who were on stable regimens of anti-epileptic drugs (AEDs) and who were admitted to an Epilepsy Monitoring Unit (EMU), General Clinical Research Center (GCRC), or similar facility for evaluation of their seizures. All subjects received a single DBF 12.5 mg dose during the Interictal State and a single DBF 12.5 mg dose during the Ictal/peri-ictal state with at least 14 days washout between the 2 doses.
Primary Outcome
Observed time to reach maximum drug concentration (Tmax)
Interventions
- DRUG Diazepam Buccal Film 12.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-05-25 |
| Est. Completion | 2018-12-21 |
| Phase | Phase 2 |
What the finished NCT03179891 record still lists
NCT03179891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Diazepam Buccal Film 12.5 mg is the first listed.
NCT03179891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03179891 about?
NCT03179891 is a clinical study titled "Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy". This Phase 2 open-label, two-way study was conducted in adult subjects with epilepsy who were on stable regimens of anti-epileptic drugs (AEDs) and who were admitted to an Epilepsy Monitoring Unit (EMU), General Clinical Research Center (GCRC), or similar facility for evaluation of their seizures. A...
What is the current status of trial NCT03179891?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2017-05-25. Estimated completion is 2018-12-21.
What interventions are being tested in trial NCT03179891?
The interventions under investigation include: Diazepam Buccal Film 12.5 mg (DRUG).
Who is sponsoring clinical trial NCT03179891?
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 NCT03179891's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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