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Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern

NCT03478982•Engage Therapeutics, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is able to provide, personally signed, and dated informed consent to participate in the study or will have a legally authorized representative sign the informed consent on his or her behalf before completing any study related procedures.
•2. Male or female ≥ 18 years of age.
•3. Has an established diagnosis of focal or generalized epilepsy or focal and generalized epilepsy with a documented history of predictable seizure episodes that includes at least one of the following:
•* Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum duration of 5 minutes
•* Episodes of a prolonged focal seizure with a minimum duration of 3 minutes
•* Episodes of multiple (≥2) seizures within a 2-hour time period
•4. Prior to randomization, has experienced ≥4 seizure episodes with predictable pattern during the last 4 weeks (qualification period) and no more than one week without a predictable seizure episode before entry into the in-patient unit.
•5. Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide,intrauterine device (IUD), surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.
•6. Subject is able to comply by the requirements of the protocol, particularly the requirements and specific Institution policies during the in-clinic stay.

Exclusion Criteria

•1. History or diagnosis of non-epileptic seizures (e.g. metabolic or pseudo-seizures).
•2. History of status epilepticus in the 6 months prior to Screening
•3. Has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 3 months
•4. Use of strong CYP 3A4 inhibitors; including azole antifungal agents (e.g., etoconazole, itraconazole), nefazodone, fluvoxamine, cimetidine, HIV protease inhibitors (e.g., ritonavir)
•5. Has severe chronic cardio-respiratory disease
•6. History of HIV-positivity.
•7. Pregnant or breast-feeding.
•8. Clinically significant renal or hepatic insufficiency (hepatic transaminases \>2 times the upper limit of normal (ULN) or creatinine ≥ 1.5 x ULN).
•9. History of acute narrow angle glaucoma, Parkinson's disease, hydrocephalus, or history of significant head trauma.
•10. Subjects who use medications to treat airways disease, such as asthma or COPD or have any acute respiratory signs/symptoms (e.g., wheezing).
+9 more criteria

Locations (67)

UAB Hospital

Birmingham, Alabama, United States

University of Arizona

Phoenix, Arizona, United States

St. Joseph's Hospital and Medical Center - Barrow Neurological Institute

Phoenix, Arizona, United States

Clinical Trials Inc

Little Rock, Arkansas, United States

Rancho Research Institute Inc.

Downey, California, United States

UCLA

Los Angeles, California, United States

Hoag Hospital

Newport Beach, California, United States

Stanford Neuroscience Health Center

Palo Alto, California, United States

Havana Research Institute LLC.

Pasadena, California, United States

University of Colorado

Aurora, Colorado, United States

Key Dates

Start Date

March 16, 2018

Primary Completion Date

December 22, 2019

Completion Date

January 4, 2020

Last Updated

February 3, 2021

Enrollment

156

ACTUAL participants

Conditions

Epilepsy

Interventions

Staccato Alprazolam

DRUG

Placebos

DRUG

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Epilepsy; Seizure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

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