Staccato Alprazolam in Panic Attack

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.

Timeline

Start

2007-05

Primary completion

2008-04

Completion

2008-04

Outcome

Missed primary endpoint

registry analysis (superiority test); RCT Placebo vs RCT Alprazolam 1 mg; p = 0.200; Fisher Exact NCT00477451 ↗

registry analysis (superiority test); RCT Placebo vs RCT Alprazolam 1 mg; p = 0.368; Wilcoxon (Mann-Whitney) NCT00477451 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alprazolam	Small molecule	1 mg	Inhaled
Subject	Alprazolam	Small molecule	2 mg	Inhaled
Background	Doxapram	Small molecule	0.5 mg/kg	Intravenous

Indications

No indication recorded.