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news.Alexza Pharmaceuticals has completed its target patient enrollment in its in-clinic, multi-center, randomized, double-blind, single-administration, placebo-controlled Phase IIa proof-of-concept clinical trial with AZ-104 in patients with migraine headache.
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The trial involves approximately 160 migraine patients with or without aura. Three doses of AZ-104 (1.25mg, 2.5mg and 5mg) were evaluated against placebo in the clinical trial. Using the International Headache Society four-point rating scale, the primary efficacy endpoint was pain-relief response at two hours post-administration.
Secondary efficacy endpoints for the trial included additional pain response assessments and other symptom assessments at various time points. Safety evaluations were made throughout the clinical trial period.
AZ-104 (staccato loxapine) is a lower-dose version of AZ-004, which is being developed to treat acute agitation in patients with schizophrenia or bipolar disorder. AZ-004 and AZ-104 are being developed through Symphony Allegro, a development collaboration formed between Alexza and Symphony Capital in 2006.