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Staccato™ Alprazolam for Inhalation in Panic Attack

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Panic Disorder   

ChemIDplus related topics:   Alprazolam    Doxapram    Doxapram hydrochloride   

U.S. FDA Resources

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

Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • the effect of treatment on the intensity and duration of the doxapram induced panic attack [ Time Frame: 2 hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of Staccato Alprazolam [ Time Frame: 4 hr ] [ Designated as safety issue: Yes ]

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

Detailed Description:

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

Criteria

Inclusion Criteria:

  1. Subjects who meet DSM-IV criteria for panic disorder, with or without agoraphobia.
  2. Subjects who have had at least one panic attack per week in each of the four weeks prior to the start of treatment and/or have a Mobility Inventory Score of 3.3 (alone) or 2.5 (accompanied).
  3. Male or female subjects who are English-speaking between 18 and 55 years of age.
  4. Female subjects who are not pregnant, or are surgically sterile or 2 years postmenopausal. If of childbearing potential, she must be using a medically-accepted method of birth control and agree to continue use of this method for at least 30 days after the study (i.e., barrier method with spermicide, steroidal contraceptive [oral, transdermal, and implanted, including Depo-Provera; contraceptives must be used in conjunction with a barrier method], or intrauterine device).
  5. Subjects who are medically healthy (i.e. without a clinically significant unstable medical condition such as asthma, coronary artery disease, renal insufficiency, etc.)
  6. Subjects who are able to give informed consent for participation.
  7. Subjects who are able to be withdrawn from current panic disorder medication because it is ineffective.

Exclusion Criteria:

  1. Subjects who have met DSM-IV criteria for substance abuse or dependence within six months of study entry must be excluded.
  2. Subjects with a baseline Acute Panic Inventory (22 item test) score of 41 or higher on the test day must be excluded.
  3. Subjects who are taking benzodiazepines, SSRIs, or medication that is effective for the prevention or treatment of the patient's panic disorder (i.e., no patient will be withdrawn for medication that is working for the purpose of entry into this study) must be excluded.
  4. Subjects who are clinically depressed must be excluded.
  5. Subjects who have received an investigational drug within 30 days (or within 5 half lives of the investigational drug) prior to test day must be excluded.
  6. Subjects with epilepsy or other convulsive disorders must be excluded.
  7. Subjects with a history of allergy or intolerance to benzodiazepines or related drugs (alprazolam, lorazepam, diazepam, etizolam, clonazepam, adinazolam) must be excluded.
  8. Subjects who test positive for alcohol or have a positive urine drug screen for illicit or disallowed drugs must be excluded. Subjects should refrain from consuming alcohol for at least 48 hours prior to dosing.
  9. Female subjects who are breastfeeding or have a positive pregnancy test must be excluded.
  10. Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results must be excluded.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477451

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

Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.

Investigators
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
First Received:   May 22, 2007
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00477451
Health Authority:   United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato™ Alprazolam, Panic Attack  

Study placed in the following topic categories:
Panic Disorder
Alprazolam
Anxiety Disorders
Mental Disorders
Doxapram

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Pharmacologic Actions
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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