Staccato™ Alprazolam for Inhalation in Panic Attack

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00477451
First received: May 22, 2007
Last updated: June 2, 2008
Last verified: June 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of a Single Dose of Staccato™ Alprazolam for Inhalation on Doxapram-Induced Panic Attack in Patients With Panic Disorder

Resource links provided by NLM:


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
Placebo Comparator: 2 Drug: placebo
Alprazolam Placebo
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203-2056
Mt. Sinai School Of Medicine
New York, New York, United States, 10029
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

No publications provided

Responsible Party: Jose Martinez, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00477451     History of Changes
Other Study ID Numbers: AMDC-002-201
Study First Received: May 22, 2007
Last Updated: June 2, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 19, 2014