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Staccato Alprazolam and Photoparoxysmal Response | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Staccato Alprazolam and Photoparoxysmal Response

Assessment of Staccato® Alprazolam on the EEG Photoparoxysmal Response in Patients With Epilepsy

NCT02351115•Alexza Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

Detailed Description

The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo. People with photosensitive epilepsy have changes on their electroencephalogram (EEG) when shown flashing lights. Three dose levels of Staccato Alprazolam will be compared to placebo. This study will also assess the level of sedation of Staccato Alprazolam compared to placebo.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female subjects between the ages of 18 to 60 years, inclusive
•Body mass index (BMI) ≥18 and ≤35 kg/m2
•Able to speak, read, and understand English and willing and able to provide written informed consent on an IRB-approved form before the initiation of any study procedures
•A diagnosis and history of a photoparoxysmal response on EEG with or without a diagnosis of epilepsy for which patients are on 0-2 concomitant antiepileptic drugs
•At least 3 of the EEGs performed during the screen visit must have a reproducible IPS-induced photoparoxysmal response (PPR) on EEG of at least 3 points on a frequency assessment scale in at least one eye condition
•In otherwise good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis
•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

Exclusion Criteria

•History of non-epileptic seizures (e.g. metabolic, structural, or pseudo-seizures)
•History of seizure worsening in response to narrow spectrum drugs
•An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
•Use of more than 2 concomitant AEDs for epilepsy treatment
•Subjects taking known inhibitors or inducers of CYP3A , including carbamazepine
•Subjects with a history of allergic reactions to alprazolam or other benzodiazepines
•Treatment with an investigational drug within 30 days (or within 5 half-lives of the investigational drug, if \>30 days) before Visit 2
•A history within the past 1 year of drug or alcohol dependence or abuse
•Positive urine screen for drugs of abuse at Visit 1 - Screening
•A history of HIV-positivity
+9 more criteria

Locations (3)

Consultants in Epilepsy & Neurology, PLLC

Boise, Idaho, United States

New York University Epilepsy Center

New York, New York, United States

University of Pennsylvania - Penn Epilepsy Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

January 1, 2015

Primary Completion Date

July 1, 2016

Completion Date

July 1, 2016

Last Updated

August 10, 2021

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

A=Placebo

DRUG

B=Inhaled Alprazolam 0.5 mg

DRUG

C=Inhaled Alprazolam 1 m

DRUG

D= Inhaled Alprazolam 2 mg

DRUG

E=Placebo

DRUG

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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: August 10, 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.

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Staccato Alprazolam and Photoparoxysmal Response

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

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