Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
Public ClinicalTrials.gov record NCT03428360. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Buccal Film (DBF) in Pediatric, Adolescent and Adult Subjects With Epilepsy
Study identification
- NCT ID
- NCT03428360
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Aquestive Therapeutics
- Industry
- Enrollment
- 149 participants
Conditions and interventions
Conditions
Interventions
- 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
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 22, 2018
- Primary completion
- Jun 24, 2020
- Completion
- Jun 24, 2020
- Last update posted
- Aug 4, 2021
2018 – 2020
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hawaii Neuroscience Center | Honolulu | Hawaii | 96187 | — |
| Consultants in Epilepsy and Neurology, PLLC | Boise | Idaho | 83702 | — |
| Clinical Research Center of New Jersey (CRCNJ) | Voorhees Township | New Jersey | 08043 | — |
| OnSite Clinical Solutions LLC | Charlotte | North Carolina | 28203 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Austin Epilepsy Care Center | Austin | Texas | 78758 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03428360, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2021 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03428360 live on ClinicalTrials.gov.