AZ-004 Phase 3 Clinical Trial Design
The first AZ-004 Phase 3 clinical trial enrolled 344 patients with schizophrenia at 24 U.S. clinical centers. The trial is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study, testing AZ-004 at two dose levels, 5 and 10 mg. The trial protocol specified that patients were eligible to receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status.
The primary endpoint for the study is the reduction in agitation as measured by the change from baseline in the PEC Score, measured at 2 hours after the first dose. The PEC Score is a commonly used endpoint in acute agitation studies and is the abbreviation for PANSS (Positive and Negative Symptom Scale) Excited Component Score. The trial protocol specified that various assessments of a patient's agitation state be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects were recorded throughout the 24-hour period.
Alexza projects that the initial results will be reported before the end of September 2008. The second Phase 3 clinical trial is projected to begin in Q3 2008. The design of the second study will be similar to the first trial, except that the patient population will be bipolar disorder patients.
Conference Call Information
The Company will host an investor conference call to discuss today's
announcement on Monday, June 9, 2008 at 5:15 p.m. Eastern Time. A replay of
the call will be available for two weeks following the event. The
conference call, replay and webcast are open to all interested parties.
Domestic callers: 1-800-299-0148
International callers: 1-617-801-9711
|SOURCE Alexza Pharmaceuticals, Inc.|
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