CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Diazepam Buccal Filmdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03222349
NCT03222349Phase 2Completed
CompareCT.gov

A Multicenter,Open Label Crossover Study to Assess the Pharmacokinetics and Safety of Diazepam Buccal Soluble Film (DBSF) in Pediatric Subjects With Epilepsy

Aquestive Therapeutics·interventional·Posted Jul 19, 2017·Updated May 26, 2021

In Brief

A Phase 2 clinical trial evaluating Diazepam Buccal Film for Epilepsy. Completed, enrolled 24 participants across 10 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesUnited States
CollaboratorsSyneos Health, Covance

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 19, 2017
Enrollment StartAug 31, 2017
Primary CompletionJan 28, 2020
Study CompletionMar 11, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.0 years ago

Interventions

Diazepam Buccal Filmdrug

Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses.