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.
Engage Therapeutics will begin in 2018 a Phase 2b clinical trial of Staccato Alprazolam in study subjects with a predictable epilepsy seizure pattern in 16 U.S. study sties. The primary objectives of this clinical trial are to assess the clinical feasibility, safety and efficacy of AZ-002 (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.
Please fill out the form below to learn more about our clinical trials and future enrollment criteria. Once recruitment is underway, and we find that you meet the criteria shown, we will be in touch.