Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern

Summary

This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and older) subjects with epilepsy with a predictable seizure pattern. These subjects have an established diagnosis of focal or generalized epilepsy with a documented history of predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject will be treated with study medication. The duration and timing of the seizure event and occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through clinical observation and confirmed with video electroencephalogram (EEG).

Timeline

Start

2018-03-16

Primary completion

2019-12-22

Completion

2020-01-04

Publications

• French J, Biton V, Dave H, Detyniecki K, Gelfand MA, Gong H, Liow K, O'Brien TJ, Sadek A, DiVentura B, Reich B, Isojarvi J. A randomized phase 2b efficacy study in patients with seizure episodes with a predictable pattern using Staccato(R) alprazolam for rapid seizure termination. Epilepsia. 2023 Feb;64(2):374-385. doi: 10.1111/epi.17441. Epub 2022 Dec 7.

Drugs

Indications