Conditions: Treatment of Induced Panic Attack
Keywords: Staccato™ Alprazolam, Panic Attack, Inhaled alprazolam
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: no

Brief summary:
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.

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.

Arms:
arm 1: Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial arm 2: Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial arm 3: Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation arm 4: Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment

Interventions: intervention 1: Inhaled placebo intervention 2: Inhaled alprazolam 1 mg intervention 3: Inhaled alprazolam 2 mg intervention 4: IV doxapram
Intervention descriptions: intervention 1: Inhaled Staccato Alprazolam Placebo intervention 2: Inhaled Staccato Alprazolam 1 mg intervention 3: Inhaled Staccato Alprazolam 2 mg intervention 4: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo

Protocol document: