Clinical trials are designed to provide information on the benefits, side effects and possible uses for new drugs and existing medications. Results from clinical trials are submitted for review to regulatory agencies, like the U.S. Food and Drug Administration (FDA), which establish safety and efficacy standards for medical products. If a medicine meets these standards, it can be approved and becomes available by prescription.
Engage Therapeutics is working to develop a new rescue therapy for people who experience uncontrolled epileptic seizures. Staccato alprazolam has been shown in a Phase 2a proof of concept clinical study to stop seizure-like activity within two minutes and has the potential to possibly be the first rescue treatment with the potential to stop the progression of individual epileptic seizures.
In 2018 Engage Therapeutics began a Phase 2b clinical trial of Staccato Alprazolam in study subjects with a predictable epilepsy seizure pattern in 40 U.S. study sites. The primary objectives of this clinical trial are to assess the clinical feasibility, safety and efficacy of STAP-001 (Staccato Alprazolam) in treating an epilepsy seizure episode.
Inclusion criteria for the Phase 2b study include an established diagnosis of partial or generalized epilepsy with a documented history of a predictable evolution of seizure episodes. If selected for the trial you will be eligible for free patient care during the inpatient portion of the trial, free study drug, and a potential stipend for your time.