Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
Status:
Completed
Trial end date:
2018-12-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Aquestive Therapeutics MonoSol Rx
Collaborators:
Covance Covance Central Laboratory Services inVentiv Health Clinical