Staccato® Loxapine Treatment of Agitation in Bipolar Disorder Patients

Condition(s) targeted: Bipolar I Disorder

Intervention: loxapine (Drug); loxapine (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alexza Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Robert S Fishman, MD, Study Director, Affiliation: Alexza Pharmaceuticals, Inc.

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

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

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

Primary outcome: Change in PANSS Excited component (PEC) score from baseline following Dose #1 of Staccato Loxapine, compared with placebo

Secondary outcome:

Clinical Global Impression-Improvement (CGI-I) score following Dose #1 of Staccato Loxapine, compared with placebo

Treatment emergent adverse events, compared with placebo

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Synergy Escondido, Escondido, California 92025, United States

Collaborative NeuroScience Network, Inc., Garden Grove, California 92845, United States

Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States

FutureSearch Trials, Austin, Texas 78756, United States

Claghorn-Lesem Research Clinic, Houston, Texas 77008, United States

Northwest Clinical Research Center, Bellevue, Washington 98004, United States

Starting date: July 2008
Last updated: October 22, 2008