Last updated on June 2019

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


Brief description of study

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).

Clinical Study Identifier: NCT03478982

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Clinical Research Institute

Stockbridge, GA United States
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Hawaii Pacific Neuroscience

Honolulu, HI United States
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GW Medical Faculty Associates

Washington, WA United States
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Thomas Jefferson University

Philadelphia, PA United States
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UT Houston

Houston, TX United States
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University of Pennsylvania

Philadelphia, PA United States
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Advanced Pharma Cr, LLC

Miami, FL United States
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Ochsner Health System

New Orleans, LA United States
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University of Arizona

Phoenix, AZ United States
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Clinical Trials Inc

Little Rock, AR United States
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Yale University

New Haven, CT United States
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NW FL Clinical Research Group LLC

Gulf Breeze, FL United States
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Mayo Clinic Florida

Jacksonville, FL United States
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NeuroMedical Research Institute

Panama City, FL United States
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Bronson Methodist Hospital

Kalamazoo, MI United States
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SRI International

West Bloomfield, MI United States
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JFK Medical Center

Edison, NJ United States
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Rutgers University

New Brunswick, NJ United States
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Mount Sinai Health System

New York, NY United States
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Lenox Hill Hospital

New York, NY United States
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Clinical Trial Network

Houston, TX United States
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The Alfred

Melbourne, Australia
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The Tower

Kingston 5, Jamaica
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Hoag Hospital

Newport Beach, CA United States
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Maine Medical Center

Scarborough, ME United States
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Austin Hospital

Hiedelberg, Australia
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Georgetown University Hospital

Washington, WA United States
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AdventHealth Orlando

Orlando, FL United States
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University of Utah Hospital

Salt Lake City, UT United States
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Recruitment Status: Open


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