CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Diazepam Buccal Film 12.5 mgdrug
Likely dose
Diazepam Buccal Film 12.5 mgfrom 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/NCT03179891
NCT03179891Phase 2Completed
CompareCT.gov

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

Aquestive Therapeutics·interventional·Posted Jun 7, 2017·Updated Sep 18, 2020

In Brief

A Phase 2 clinical trial evaluating Diazepam Buccal Film 12.5 mg for Epilepsy. Completed, enrolled 35 participants across 11 sites.

Detailed Summary

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 Details

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

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 7, 2017
Enrollment StartMay 25, 2017
Primary CompletionJul 25, 2018
Study CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.1 years ago

Interventions

Diazepam Buccal Film 12.5 mgdrug

All subjects received a single dose of DBF 12.5 mg during the interictal state and during the ictal/peri-ictal state with at least 14 days washout between the 2 treatment periods