NCT00721955

Staccato Loxapine in Agitated Patients With Bipolar Disorder

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Patients With Bipolar I Disorder and Acute Agitation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

Detailed description

This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Inhaled Placebo	Inhaled loxapine Placebo, may repeat after 2 hours x 2
DRUG	Inhaled loxapine 5 mg	Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2
DRUG	Inhaled loxapine 10 mg	Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-07-25
• Last updated: 2017-07-26
• Results posted: 2017-06-29

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study