The drug, MK-0974, was generally well tolerated in the study. Responses specific to other measures, such as migraine-associated symptoms, functional disability and use of additional rescue medications also were reported. If approved, the drug may be the first in a new class of migraine treatments since the approval of the first triptan drug in 1991, said Merck.
A total of 420 adult patients who experienced migraine attacks, were randomized to treat a moderate or severe migraine attack with MK-0974 given orally at a range of doses from 25mg to 600mg, or rizatriptan 10mg, or placebo.
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. The proportion of patients reporting pain relief at two hours for those treated with MK-0974 was 68.1% and 69.5% for rizatriptan compared to 46.3% for placebo.
For the secondary endpoint of 24-hour sustained pain-freedom, 39.6% of patients on 300mg, 22% for 400mg, and 32% for600 mg of MK-0974 responded. In comparison, 18.4% of patients were pain-free over the period for rizatriptan and 11% for placebo. Other secondary goals showed a similar patter, said Merck.
“The findings of this early-stage trial demonstrate the therapeutic potential of MK-0974 for the acute treatment of migraines,” said Tony Ho, senior director of Clinical Neuroscience, Merck Research Laboratories. “Larger clinical trials, such as those now underway, will provide more insight into the efficacy and safety profile of MK-0974.”