NCT00369577

Staccato Loxapine in Agitation (Proof of Concept)

A Multi-center, Randomized, Double-blind, Placebo-controlled, Single Dose Efficacy and Safety Study of StaccatoTM Loxapine for Inhalation in Schizophrenic Patients With Agitation.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients. The study will be conducted in 120 agitated schizophrenic patients - either newly admitted to a hospital setting or a research unit for acute agitation or already in hospital for chronic underlying conditions. Patients meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to Staccato Placebo. Following administration of study drug, assessment of agitation state will be conducted at serial time points using standard agitation scales over a 24 hour period.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Inhaled Placebo	Inhaled Placebo, single dose
DRUG	Inhaled Loxapine 5 mg	Inhaled Staccato Loxapine 5 mg, single dose
DRUG	Inhaled Loxapine 10 mg	Inhaled Staccato Loxapine 10 mg, single dose

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2006-08-29
• Last updated: 2018-01-02
• Results posted: 2018-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study