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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Inhaled Staccato Alprazolam Placebo
Inhaled Staccato Alprazolam 1 mg
Inhaled Staccato Alprazolam 2 mg
SUNY Downstate Medical Center
Brooklyn, New York, United States
New York State Psychiatric Institute
New York, New York, United States
Mt. Sinai School Of Medicine
New York, New York, United States
Number of Participants With Doxapram-induced Panic Attack
doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)
Time frame: 0 to 2 hours
Duration of the Doxapram-induced Panic Attack
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)
Time frame: 1 hr post-dose
Borg Max Change From Baseline
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 frame: 45 minutes
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0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo