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Staccato Loxapine in Agitation (Proof of Concept)

NCT00369577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2018-01-02

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Zimbroff, MD · Pacific Clinical Research Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2007-01-31
Completion
2007-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00369577 on ClinicalTrials.gov