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Staccato Alprazolam in Panic Attack

NCT00477451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-06-16

Study results available
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Summary

We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in patients with panic disorder.

Conditions

  • Treatment of Induced Panic Attack

Interventions

DRUG

Inhaled placebo

Inhaled Staccato Alprazolam Placebo

DRUG

Inhaled alprazolam 1 mg

Inhaled Staccato Alprazolam 1 mg

DRUG

Inhaled alprazolam 2 mg

Inhaled Staccato Alprazolam 2 mg

DRUG

IV doxapram

0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sanjay Mathew, MD · Mt. Sinai School of Medicine

  • Jeremy Coplan, MD · State University of New York - Downstate Medical Center

  • Laszlo Papp, MD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-04-30
Completion
2008-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00477451 on ClinicalTrials.gov