An Open-Label Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Buccal Soluble Film (DBSF) in Adult Subjects With Epilepsy.

An Open-Label Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Buccal Soluble Film (DBSF) in Adult Subjects With Epilepsy.
Recruiting
18 years - 99 years
All
Phase 3

Brief description of study

You are being asked to be in this study because you have epilepsy and you take epilepsy medication. Aquestive Therapeutics (the study Sponsor) has begun a research study of an investigational drug called Diazepam Buccal Soluble Film or DBSF as a possible treatment for patients with epilepsy. An investigational drug is one that has not been approved by the United States (US) Food and Drug Administration (FDA).

Detailed description of study

Diazepam Buccal Soluble Film)is an investigational seizure rescue medication that is placed against the inside of the cheek. The film is a small thin strip and contains the medicine diazepam. It will stick to the inside of the cheek and then dissolve in a few minutes. Diazepam Buccal Soluble Film is being developed to offer patients with epilepsy another treatment option when compared to the currently available Diastat® AcuDial™ rectal gel.

The main purpose of this study is to learn about the safety of the study medication when taken to treat your seizures and how comfortable you are when you use it. This study will also look at how easy it is to use the study medication and how it may affect the
quality of your life.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: epilepsy,seizures
  • Age: 18 years - 99 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 828955

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