California, USA-based MAP Pharmaceuticals has updated investors on the progress of two current Phase III clinical programs.
Initial enrollment for a trial of the firm's Unit Dose Budesonide, for children with asthma, completed in September 2008, and all patients have now completed the treatment period. In the multicenter, randomized, double-blind, placebo-controlled trial in around 360 children with asthma, from 12 months to eight years of age, patients received either 0.25mg UDB, 0.135mg UDB or placebo twice a day over a 12-week treatment period. The co-primary efficacy endpoints for the study are the change in night-time and daytime composite symptom scores.
An initial trial of MAP0004 in the acute treatment of migraine, on the other hand, is expected to complete enrollment by the end of the month. The multicenter, randomized, double-blind, placebo-controlled trial in approximately 850 migraine sufferers who will be evaluated for the treatment of a single migraine is part of a special protocol assessment with the Food and Drug Administration.
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