Staccato Loxapine in Agitated Patients With Bipolar Disorder

Phase 3

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: Inhaled Placebo; Drug: Inhaled loxapine 5 mg; Drug: Inhaled loxapine 10 mg

• Registration Number: NCT00721955
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Status Verified: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2017-03-13
• Results First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-06-28
• Results First Posted: 2017-06-29
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled Placebo	Inhaled Placebo	Inhaled Staccato Placebo, may repeat after 2 hours x 2
Inhaled Loxapine 5 mg	Inhaled loxapine 5 mg	Inhaled Staccato Loxapine 5 mg, may repeat after 2 hours x 2
Inhaled Loxapine 10 mg	Inhaled loxapine 10 mg	Inhaled Staccato Loxapine 10 mg, may repeat after 2 hours x 2

Primary Outcome Measures

Name	Time	Method
Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo	Baseline and 2 hours	The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.

Secondary Outcome Measures

Name	Time	Method
CGI-I Responders	Baseline and 2 hours	Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo	Baseline and 2 hours	Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.

Trial Locations

Locations (6)

Collaborative NeuroScience Network, Inc.; 🇺🇸 Garden Grove, California, United States

Synergy Escondido; 🇺🇸 Escondido, California, United States

FutureSearch Trials; 🇺🇸 Austin, Texas, United States

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Claghorn-Lesem Research Clinic; 🇺🇸 Houston, Texas, United States