Staccatoâ¢ Alprazolam for Inhalation in Panic Attack
Information source: Alexza Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Panic Attack
Intervention: placebo (Drug); alprazolam (Drug)
Phase: Phase 2
Sponsored by: Alexza Pharmaceuticals, Inc.
Official(s) and/or principal investigator(s):
Sanjay Mathew, MD, Principal Investigator, Affiliation: Mt. Sinai School of Medicine
Jeremy Coplan, MD, Principal Investigator, Affiliation: State University of New York - Downstate Medical Center
Laszlo Papp, MD, Principal Investigator, Affiliation: New York State Psychiatric Institute
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.
Official title: Investigation of a Single Dose of Staccato™ Alprazolam for Inhalation on Doxapram-Induced Panic Attack in Patients With Panic Disorder
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: the effect of treatment on the intensity and duration of the doxapram induced panic attack
Secondary outcome: Safety and tolerability of 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,
Minimum age: 18 Years.
Maximum age: 55 Years.
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.
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
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.
Locations and Contacts
Mt. Sinai School Of Medicine, New York, New York 10029, United States
SUNY Downstate Medical Center, Brooklyn, New York 11203-2056, United States
New York State Psychiatric Institute, New York, New York 10021, United States
Starting date: May 2007
Ending date: April 2008
Last updated: June 2, 2008