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).
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.
It is expected that this study will enroll about 115 subjects to take part in this research at
approximately 50 sites across the United States, Canada, Australia, and Jamaica. This
study involves a stay in an inpatient unit (overnight) for 2 to 8 days. Your participation in
this study is expected to last up to 12 weeks total (screening to follow-up).