With no means of stopping or preventing seizures, safety is a chief concern of patients who experience prolonged or ongoing seizure activity. Staccato Alprazolam is a small, handheld device that can be easily carried in a purse or backpack. We are currently studying Staccato Alprazolam for its ability to stop seizures early.
We believe that Staccato Alprazolam could, if approved, provide patients with epilepsy and their caregivers with the power to stop seizures and live with more peace of mind. By participating in the clinical trial, you’ll be an important part of our journey to potentially bring the community an epilepsy rescue treatment we desperately need. Find the clinical trial site nearest you.
Phase 2b Clinical Trial Participant Eligibility Requirements
We’re seeking adults living with focal or generalized seizures for a Phase 2b clinical trial of Staccato Alprazolam in study sites across the United States. This clinical trial aims to assess the clinical feasibility, safety and efficacy of Staccato Alprazolam in treating epileptic seizures.
The Phase 2b study aims to assess the efficacy of Staccato Alprazolam in treating naturally occurring seizures. Some of the criteria for participation include:
- Age 18 years or older
- Diagnosis of focal or generalized epilepsy
- Documented history of seizure episodes that include at least one of the following:
- Generalized seizure episodes that start with a flurry of absence seizures or myoclonic seizures that last at least five minutes
- Episodes of prolonged focal seizures that last at least three minutes
- Episodes of multiple (≥2) seizures within a 2-hour time period
StATES Clinical Trial Details
StATES, short for Staccato Alprazolam Terminates Epileptic Seizures, is a double-blind, placebo-controlled, inpatient, dose-ranging efficacy study of Staccato Alprazolam (STAP-001) in 100 subjects with epilepsy who have a predictable seizure pattern.
The study is eight weeks in length, including a week-long inpatient stay and follow-up. After patients are initially screened and followed for four weeks to ensure eligibility, they are then admitted to an inpatient facility (either a CRU or EMU) in anticipation of a seizure. After the seizure event, the patient will be given one dose of STAP-001 or a placebo. The patient will then remain in the inpatient facility and monitored for at least 24 hours after dosing. Following discharge, a study coordinator will follow up with the participant via phone 12–16 days after the patient received the study drug (STAP-001) or placebo.
Participating in the Clinical Trial
Clinical trial participants will receive a stipend for their time and compensation for travel expenses. Your participation in this clinical trial is an important contribution to epilepsy research; the sooner that we are able to complete the clinical trial, the sooner we can advance our research to bring this groundbreaking seizure rescue treatment to the epilepsy community.