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Sponsored by: |
Alexza Pharmaceuticals, Inc. |
Information provided by: | Alexza Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00477451 |
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.
Condition | Intervention | Phase |
Panic Attack |
Drug: placebo Drug: alprazolam |
Phase II |
MedlinePlus related topics: | Panic Disorder |
ChemIDplus related topics: | Alprazolam Doxapram Doxapram hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Investigation of a Single Dose of Staccato™ Alprazolam for Inhalation on Doxapram-Induced Panic Attack in Patients With Panic Disorder |
Enrollment: | 40 |
Study Start Date: | May 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2: Placebo Comparator |
Drug: placebo
Alprazolam Placebo
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1: Experimental |
Drug: alprazolam
Staccato Alprazolam
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The study will be conducted at multiple centers. A total of 42 male and female panic disorder patients will be studied. The first 6 subjects will receive Staccato Alprazolam 1 mg open label to validate the dose selection. The remaining 36 subjects will be treated with either Staccato Alprazolam at the chosen dose; or with Staccato Placebo in a double blind, randomized order.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |||||
Mt. Sinai School Of Medicine | |||||
New York, New York, United States, 10029 | |||||
SUNY Downstate Medical Center | |||||
Brooklyn, New York, United States, 11203-2056 | |||||
New York State Psychiatric Institute | |||||
New York, New York, United States, 10021 |
Alexza Pharmaceuticals, Inc. |
Principal Investigator: | Sanjay Mathew, MD | Mt. Sinai School of Medicine |
Principal Investigator: | Jeremy Coplan, MD | State University of New York - Downstate Medical Center |
Principal Investigator: | Laszlo Papp, MD | New York State Psychiatric Institute |
Responsible Party: | Mount Sinai School of Medicine ( Jose Martinez ) |
Study ID Numbers: | AMDC-002-201 |
First Received: | May 22, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00477451 |
Health Authority: | United States: Food and Drug Administration |
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