09.05.06
MAP Pharmaceuticals has initiated patient dosing in a Phase II trial evaluating MAP0004 for the treatment of acute migraine headaches. MAP0004 is an inhaled drug formulation of dihydroergotamine mesylate (DHE) administered with the company's Tempo Inhaler. The therapy is intended to offer fast onset of action similar to an IV infusion, but without the need for an injection in a hospital or doctor's office setting.
The Phase II trial will be conducted in as many as 10 sites in the U.S. as a randomized, double-blind, placebo-controlled study in approximately 100 migraine patients. The efficacy of three doses of MAP0004 will be assessed, with the primary endpoint for the trial being pain relief at two hours. Additional endpoints include relief from nausea, phonophobia and photophobia. Safety evaluations will be made throughout the trial period.
The Phase II trial will be conducted in as many as 10 sites in the U.S. as a randomized, double-blind, placebo-controlled study in approximately 100 migraine patients. The efficacy of three doses of MAP0004 will be assessed, with the primary endpoint for the trial being pain relief at two hours. Additional endpoints include relief from nausea, phonophobia and photophobia. Safety evaluations will be made throughout the trial period.