NCT02351115

Staccato Alprazolam and Photoparoxysmal Response

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	A=Placebo
DRUG	B=Inhaled Alprazolam 0.5 mg
DRUG	C=Inhaled Alprazolam 1 m
DRUG	D= Inhaled Alprazolam 2 mg
DRUG	E=Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-01-30
• Last updated: 2021-08-10
• Results posted: 2021-08-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study