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Staccato Alprazolam in Panic Attack

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00477451
First received: May 22, 2007
Last updated: June 15, 2017
Last verified: June 2008
May 22, 2007
June 15, 2017
May 2007
April 2008   (Final data collection date for primary outcome measure)
  • Number of Participants With Doxapram-induced Panic Attack [ Time Frame: 0 to 2 hours ]
    doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)
  • Duration of the Doxapram-induced Panic Attack [ Time Frame: 1 hr post-dose ]
    Length of time from the doxapram injection to the time at which the acute panic inventory (API) value returns to within 10 points of the baseline API value. 0=never exceeded 0, 61=exceeded by more than 10 points still at end of assessment of 60 minutes. Thus each would have a duration whether or not they had a panic attack (DIPASI)
Two primary endpoints to assess the effect of treatment on: 1) the intensity of the doxapram induced panic attack and 2) the duration of the doxapram-induced panic attack. [ Time Frame: 2 hr ]
Complete list of historical versions of study NCT00477451 on ClinicalTrials.gov Archive Site
Borg Max Change From Baseline [ Time Frame: 45 minutes ]
Subjects asked to "Point to the number (0 to 10) which matches how breathless you feel now" where 0=nothing at all to 10=very, very strong
Time to Doxapram-induced panic attack of sufficient intensity (DIPASI), Acute Panic Inventory (API) total and subscales time points, API rate of change, Borg Dyspnea Scale, Ordinal Anxiety Scale. [ Time Frame: 2 hr ]
Not Provided
Not Provided
 
Staccato Alprazolam in Panic Attack
Investigation of a Single Dose of Staccato™ Alprazolam for Inhalation on Doxapram-Induced Panic Attack in Patients With Panic Disorder
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Treatment of Induced Panic Attack
  • 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
  • Placebo Comparator: RCT Placebo
    Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial
    Interventions:
    • Drug: Inhaled placebo
    • Drug: IV doxapram
  • Experimental: RCT Alprazolam 1 mg
    Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial
    Interventions:
    • Drug: Inhaled alprazolam 1 mg
    • Drug: IV doxapram
  • Experimental: Open Label Inhaled Alprazolam 1 mg
    Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation
    Interventions:
    • Drug: Inhaled alprazolam 1 mg
    • Drug: IV doxapram
  • Experimental: Initial Inhaled Alprazolam 2 mg
    Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment
    Interventions:
    • Drug: Inhaled alprazolam 2 mg
    • Drug: IV doxapram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
April 2008
April 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00477451
AMDC-002-201
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Yes
IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
Not Provided
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
Alexza Pharmaceuticals, Inc.
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP