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| Sponsor: | Alexza Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Alexza Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00477451 |
Purpose
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 |
| 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
|
| 1: Experimental |
Drug: alprazolam
Staccato Alprazolam
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| 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 |
More Information
| Responsible Party: | Mount Sinai School of Medicine ( Jose Martinez ) |
| Study ID Numbers: | AMDC-002-201 |
| Study First Received: | May 22, 2007 |
| Last Updated: | June 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00477451 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Staccato™ Alprazolam, Panic Attack |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Pharmacologic Actions Panic Disorder |
Alprazolam Anxiety Disorders Mental Disorders Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents |