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NCT03222349 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy
A Phase 2 study of Epilepsy, sponsored by Aquestive Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 10
- Study locations
NCT03222349: Completed Phase 2 study of Epilepsy, sponsored by Aquestive Therapeutics.
NCT03222349 is a Phase 2 study of Epilepsy that has completed, run by Aquestive Therapeutics. The registered enrollment target is 24 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03222349, a Phase 2 study of Epilepsy, has completed, sponsored by Aquestive Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 10
- Study locations
Study Summary
Open-label study to assess the pharmacokinetics of a single diazepam buccal film (DBF) dose in 3 age cohorts of pediatric patients with epilepsy (age 2-5 years, age 6-11 years, and age 12-16 years). Subjects in the 6-11 years and 12-16 years age cohorts received a single DBF dose during the interictal period (Period A) and ictal/peri-ictal period (Period B) with at least 14 days washout between doses. Subjects in the age 2-5 years age cohort received a single DBF dose only during the ictal/peri-ictal period (Period B).
Primary Outcome
AUC calculated from time 0 (dosing) to 4 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Conditions Studied
Interventions
- DRUG Diazepam Buccal Film
Study Locations (10)
New York
- Icahn School of Medicine at Mount Sinai - New York
- University of Rochester - Rochester
Texas
- Dell Children's Medical Center - Austin
- Austin Epilepsy Care Center - Austin
Arizona
- University of Arizona - Tucson
Florida
- NW FL Clinical Research Group, LLC - Gulf Breeze
New Jersey
- Children's St. Peters University Hospital - New Brunswick
North Carolina
- Onsite Clinical Solutions LLC - Charlotte
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-08-31 |
| Est. Completion | 2020-03-11 |
| Phase | Phase 2 |
What the finished NCT03222349 record still lists
NCT03222349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Diazepam Buccal Film is the first listed.
NCT03222349 lists 10 locations in 8 states (New York, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT03222349 about?
NCT03222349 is a clinical study titled "Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy". Open-label study to assess the pharmacokinetics of a single diazepam buccal film (DBF) dose in 3 age cohorts of pediatric patients with epilepsy (age 2-5 years, age 6-11 years, and age 12-16 years). Subjects in the 6-11 years and 12-16 years age cohorts received a single DBF dose during the interict...
What is the current status of trial NCT03222349?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2017-08-31. Estimated completion is 2020-03-11.
What conditions does trial NCT03222349 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT03222349?
The interventions under investigation include: Diazepam Buccal Film (DRUG).
Who is sponsoring clinical trial NCT03222349?
This trial is sponsored by Aquestive Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03222349 being conducted?
This trial has 10 study locations across Arizona, Florida, New Jersey, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03222349's enrollment target sits among peer trials
24 123rd of 160 higher than 32 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy 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.
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