NCT00477451

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment of Induced Panic Attack

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-05-23
• Last updated: 2017-06-16
• Results posted: 2017-06-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study