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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 is a Phase 3 study that has completed, run by Aquestive Therapeutics. The registered enrollment target is 149 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03428360
The ClinicalTrials.gov registry entry for NCT03428360 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aquestive Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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