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Merck's Investigational Migraine Treatment MK-0974 Significantly,Improved Migraine Pain on Several Efficacy Measures in a Phase II,Study

th migraine. An innovative, two-stage, adaptive dose-ranging design formulated through computer simulation was used to facilitate optimal dose selection.

A total of 420 adult patients who experienced migraine attacks, as defined by the International Headache Society criteria, were randomized (330 took drug) to treat a moderate or severe migraine attack with MK-0974 given orally at doses of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, or 600 mg, or rizatriptan 10 mg, or placebo. Patients enrolled were primarily female (89 percent) with an average age of 41 years. Most treated headaches were moderate in baseline severity and did not have aura.

The first stage of the study evaluated all doses of MK-0974 with rizatriptan and placebo. When a preset number of migraine attacks were treated, an interim efficacy analysis was conducted resulting in dropping the four lowest doses of MK-0974 based on a pre-specified algorithm. The second stage of the study continued with randomization of patients to MK-0974 300 mg, 400 mg or 600 mg or to rizatriptan 10 mg or placebo.

Overall treatment effect was analyzed by comparing the average response of the MK-0974 treatment groups (300 mg, 400 mg and 600 mg) to the response observed in the placebo group. The study was not powered to detect differences between the individual doses of MK-0974 or between MK-0974 doses and rizatriptan.

Study results

For the primary endpoint, the overall treatment effect of MK-0974 in relieving migraine pain (reduction from severe or moderate to mild or none) two hours after dosing was significant compared to placebo (p=0.015). The proportion of patients reporting pain relief at two hours for those treated with MK-0974 was 68.1 percent (300 mg; n=38), 48.2 percent (400 mg; n=45) and 67.5 percent (600 mg, n=40); and 69.5 percent for rizatriptan (n=34) compared to 46.3 percent for placebo (n=115).

A similar pattern was observed for secondary measures in which the overall
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