Alexza Completes Enrollment In AZ-004 Phase IIa Clinical Trial In Schizophrenic Patients With Acute Agitation
- Friday, January 19, 2007, 20:02
- Clinical Trials / Drug Trials, Schizophrenia
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Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has completed patient enrollment in its Phase IIa clinical trial of AZ-004 (Staccato(R) loxapine). AZ-004 is an inhalation product candidate being developed for the acute treatment of agitation in schizophrenic patients.
The Phase IIa clinical trial was a multi-center, randomized, double-blind, placebo-controlled study of 120 patients in an in-patient clinical setting. In the trial, two doses of AZ-004 (5 and 10 mg), and placebo were tested. The primary aim of the clinical trial was to assess the safety and efficacy of a single dose of AZ-004 in acutely treating agitation in schizophrenic patients. Assessments of a patient’s agitation state were conducted at serial time points using both standard agitation scales and objective measures of patient’s movement over a 4-hour period, with follow-up assessments for the next 20 hours. The change in the PANSS Excited Component (PEC) scale was the primary efficacy measure for the clinical study. Safety evaluations were made throughout the clinical trial period.
“This clinical trial is significant in demonstrating that acutely-agitated schizophrenic patients can self-administer AZ-004 in a clinical setting,” said James V. Cassella, PhD, Alexza Senior Vice President of R&D. “We completed enrollment in this proof-of-concept study in less than 4 months, which we believe shows the viability of this treatment option in this patient population. We believe we are on track to provide initial results from this clinical trial during the second quarter of 2007.”
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