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news.Alexza Pharmaceuticals has initiated its first Phase III clinical trial with AZ-004 or Staccato loxapine for the treatment of acute agitation in patients with schizophrenia or bipolar disorder.
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The first AZ-004 Phase III clinical trial is designed to enroll approximately 300 schizophrenic patients with acute agitation at 25 US clinical centers. The trial is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and will test AZ-004 at two dose levels, 5 and 10mg. Patients may receive up to three doses of study drug in a 24-hour period, depending on their clinical status.
The primary endpoint for the study is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, measured at two hours after the first dose. Various assessments of a patient’s agitation state will be conducted at serial time points using standard agitation scales over the first four-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period.