Study of Staccato Alprazolam in Subjects with Epilepsy with a Predictable Seizure Pattern
Brief description of study
You are being asked to participate in this study because you have a diagnosis of focal
and/or generalized epilepsy with a documented history of predictable seizure episodes,
and experience repeated seizures that require treatment in addition to your
maintenance anti-epileptic drugs (AED).
Detailed description of study
The purpose of this research is to test whether a single-use, hand-held, drug-device combination product called STAP-001 is effective, safe and easy to use in a clinical setting. Throughout this consent form STAP-001 (alprazolam and placebo) will be referred to as the study drug. The study drug provides quick delivery of the medication alprazolam to all parts of the body by having subjects breathe in an aerosol form of alprazolam. Alprazolam is approved for the management of anxiety disorder, or the short-term relief of symptoms of anxiety, and for the treatment of panic disorder.
Alprazolam is in a class of approved drugs called benzodiazepines that are used for
emergency treatment of seizures. However, alprazolam is not yet approved for the
treatment of seizures. In this study the device and the use of an aerosol form of
alprazolam are experimental, and their use to treat acute seizures has not been
approved by the U.S. Food and Drug Administration.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
epilepsy,seizures
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Age: Between 18 Years - 99 Years
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Gender: All
Updated on
14 Jul 2023.
Study ID: 829799