Staccato® Loxapine Treatment of Schizophrenic Patients With Agitation

Schizophrenic Patients With Acute Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628589
• Other study ID #: AMDC-004-301
• Secondary ID: 7 December 2007
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2008
• Last updated: June 10, 2008
• Start date: February 2008
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female adult patients with schizophrenia and acute agitation

Exclusion Criteria:

• Agitation caused primarily by acute intoxication

• History of drug or alcohol dependence

• Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Schizophrenic Patients With Acute Agitation

Intervention

Drug:
• loxapine
Staccato Loxapine, 5 mg
• loxapine
Staccato Loxapine, 10 mg
• placebo
Staccato Placebo

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PANSS Excited Component (PEC) score from baseline following Dose #1 of Staccato Loxapine, compared with placebo		2 hr	No
Secondary	Clinical Global Impression-Improvement (CGI-I) score following Dose #1 of Staccato Loxapine, compared with placebo		2 hr	No
Secondary	Treatment emergent adverse events, compared with placebo		24 hr	Yes