Clinical Trial Studying the Staccato Inhaler Device with Alprazolam Currently Recruiting Participants in Michigan

Purpose

The StATES (Staccato Alprazolam Terminates Epileptic Seizures) study is designed to evaluate the safety and efficacy of the Staccato Inhaler Device with Alprazolam in terminating seizure activity once it has begun.


Detailed Description

The StATES study 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) through clinical observation and confirmed with video electroencephalogram (EEG).


Eligibility

  • Diagnosed with epilepsy by a medical professional
  • 18 years of age or older
  • Diagnosed with generalized or focal epilepsy
  • Experience frequent (e.g., weekly) seizures
  • Do NOT have a history or diagnosis of other non-epileptic seizures
  • Do NOT use medication that treats an airway disease, such as asthma or COPD


Contacts and Locations:

For more information or to enroll, go to epilepsyhealthstudy.com

Study sites in Michigan:

Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Contact: Anne Macneil, Anne.macneil@michmer.com
Principal Investigator: Yanny Philips, DO

SRI International
West Bloomfield, Michigan, 48322
Contact: Anne MacNeil, Anne.macneil@michmer.com
Principal Investigator: Steven Schechter, MD

University of Michigan
Ann Arbor, Michigan, 48109 Contact: Jamie Guyot, Jamieann@med.umich.edu
Principal Investigator: Daniela Minecan, MD


Full Study Information