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Staccato® Loxapine Treatment of Schizophrenic Patients With Agitation

Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenic Patients With Acute Agitation

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.

Summary

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

Clinical Details

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

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.

Eligibility

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

Criteria:

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

Locations and Contacts

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

Starting date: February 2008
Last updated: June 10, 2008

Page last updated: August 23, 2015

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