Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
Public ClinicalTrials.gov record NCT03179891. 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.
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Official title
A Multicenter, Open Label, Crossover Study to Assess the Pharmacokinetics and Safety of Diazepam Buccal Soluble Film (DBSF) in Adult Subjects With Epilepsy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03179891
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- May 25, 2017 (Actual)
- Primary completion
- Jul 25, 2018 (Actual)
- Completion
- Dec 21, 2018 (Actual)
- Last update posted
- Sep 18, 2020
2017 – 2018
United States locations
- U.S. sites
- 11
- U.S. states
- 11
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Health Sciences Center | Tucson | Arizona | 85724-5023 | — |
| Rancho Research Institute | Downey | California | 90242 | — |
| Yale University School of Medicine-Comprehensive Epilepsy Center | New Haven | Connecticut | 06520-8018 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Onsite Clinical Solutions LLC | Charlotte | North Carolina | 28203 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Austin Epilepsy Care Center | Austin | Texas | 78758 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23219 | — |
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 NCT03179891, 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 Sep 18, 2020 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03179891 live on ClinicalTrials.gov.