Staccato® Loxapine Treatment of Schizophrenic Patients With Agitation
Information source: Alexza Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 placeboTreatment 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
Ending date: May 2008
Last updated: June 10, 2008
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