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news.Map Pharmaceuticals has completed the special protocol assessment process with the FDA for the first Phase III clinical trial of its MAP0004 product candidate, and has reached agreement with the Agency on the design of the protocol.
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This multi-center Phase III trial will include a randomized, double blind, placebo-controlled component to evaluate the efficacy and safety of MAP0004 in treating a single acute attack of migraine in approximately 850 patients followed by a 12-month open-label safety assessment. The primary efficacy endpoints will be pain relief at two hours, and freedom from nausea, photophobia and phonophobia at two hours. The study, if successful, could support the potential approval of MAP0004 as a treatment for migraine.
MAP0004 is a proprietary orally inhaled version of dihydroergotamine intended to treat migraine. MAP0004 is designed to be an easy to use, non-invasive, at-home therapy that patients self-administer using the company’s proprietary hand-held Tempo inhaler.
Stephen Shrewsbury, chief medical officer of Map Pharmaceuticals, said: “We look forward to initiating this trial in early 2008.”