Staccato® Loxapine Treatment of Agitation in Bipolar Disorder Patients

Bipolar I Disorder Clinical Trial

— AMDC-004-302  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721955
• Other study ID #: AMDC-004-302
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2008
• Last updated: October 22, 2008
• Start date: July 2008
• Est. completion date: October 2008

Study information

• Verified date: October 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 bipolar 1 disorder 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: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female adult patients with bipolar 1 disorder 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

• Bipolar I Disorder

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
United States	FutureSearch Trials	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Synergy Escondido	Escondido	California
United States	Collaborative NeuroScience Network, Inc.	Garden Grove	California
United States	Claghorn-Lesem Research Clinic	Houston	Texas

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	Yes
Secondary	Treatment emergent adverse events, compared with placebo		24 hr	Yes