Expired Study
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Atlanta, Georgia 30308


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00628589


Primary Contact:

Study Director
Robert S Fishman, MD
Alexza Pharmaceuticals, Inc.


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30308
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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