Alexza Pharmaceuticals, Inc. has completed patient enrollment in its Phase IIb clinical trial of AZ-001 (Staccato prochlorperazine) in patients with migraine headaches. AZ-001 is an inhalation product candidate being developed for the acute treatment of migraine headaches.
The Phase IIb clinical trial is an outpatient, multi-center, randomized, double-blind, single-dose, placebo-controlled study with a targeted enrollment of 400 migraine patients, with and without aura. In the trial, three doses of AZ-001 (5, 7.5 and 10 mg) and placebo are being tested. Using the International Headache Society (IHS) 4-point rating scale, the primary efficacy endpoint for the trial is headache pain relief at 2 hours post-dose. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. Safety evaluations are also being made throughout the clinical trial.
"This AZ-001 clinical trial is our first study with a Staccato product candidate in a non-clinical, at-home setting," said James V. Cassella, PhD, Senior Vice President of R&D at Alexza. "We have closed enrollment for the study and we believe we are on track to provide initial results from this clinical trial by the end of March 2007."
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