Staccato Loxapine in Agitated Patients With Bipolar Disorder

Phase 3CompletedNCT00721955

Alexza Pharmaceuticals, Inc.314 enrolled

Overview

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

314

Conditions

Bipolar I Disorder

Interventions

Inhaled PlaceboDRUG

Inhaled loxapine Placebo, may repeat after 2 hours x 2

Inhaled loxapine 5 mgDRUG

Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2

Inhaled loxapine 10 mgDRUG

Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (6)

Synergy Escondido

Escondido, California, United States

Collaborative NeuroScience Network, Inc.

Garden Grove, California, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

FutureSearch Trials

Austin, Texas, United States

Outcomes

Primary Outcomes

Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo

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.

Time frame: Baseline and 2 hours

Secondary Outcomes

Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo

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.

Time frame: Baseline and 2 hours

CGI-I Responders

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)

Time frame: Baseline and 2 hours

Data from ClinicalTrials.gov

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