WASHINGTON – AMG 334, a fully human monoclonal antibody that blocks the calcitonin gene-related peptide (CGRP) receptor, is an effective treatment for episodic migraine when administered in 70-mg doses, Dr. Robert Lenz of Amgen said at the annual meeting of the American Headache Society.
The researchers randomized 483 patients with episodic migraine – characterized as experiencing at least 4 and no more than 14 migraines per month – into cohorts receiving a 70-mg dose (107 subjects), a 21-mg dose (108 patients), a 7-mg dose (108 patients), or a placebo (160 subjects). The primary endpoint measure was a reduction in the number of migraine episodes from baseline to 12 weeks. Secondary endpoints were overall reduction in migraine episodes per month, the number of patients who experienced an episode reduction of at least 50%, and safety/tolerability factors. Women comprised 81% of the study population, and mean age was 41 years.
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Patients on the 70-mg dosage of AMG 334 had a mean reduction of 3.40 migraine days per month, versus the 2.28 mean migraine-days reduction observed in the placebo cohort (P = .021). In secondary outcomes, 46.5% of patients taking 70 mg of AMG 334 experienced an episode reduction per month of at least 50%, compared with only 29.9% in the placebo cohort (P = .011); reductions were also seen in monthly headache days (3.54 in 70-mg cohort vs. 2.39 in placebo cohort, P = .022) and monthly migraine specific–medication use days (1.64 in 70-mg cohort vs. 0.69 in placebo cohort, P = .004).
There were no significant differences in the safety and tolerability data between the AMG 334 70-mg patients and those taking the placebo. Subjects in the cohorts receiving 7-mg and 21-mg doses of AMG 334 did not experience a statistically significant reduction in mean migraine days.
Dr. Lenz is employed by Amgen and receives a salary, stock options, and ownership interests.