Antibodies Block Migraine in Preliminary Studies

Results of 2 new studies presented at the annual meeting of the American Academy of Neurology in Philadelphia suggest humanized anti-calcitonin gene-related peptide (CGRP) antibodies may be safe and effective as treatments to prevent migraines in patients with a high monthly frequency of migraines.

David Dodick, MD, of the Mayo Clinic in Phoenix, AZ, said there is room for cautious optimism about new medications to target the mechanisms behind migraine based on the results of his and another small randomized, double-blind, placebo-controlled studies presented at the conference. The second study, presented by Peter Goadsby, MD, PhD, of the University of California, San Francisco, also reported on trials of antibodies to CGRP.

In Dodick’s study of 218 people, the medication (LY2951742) was given every 2 weeks by subcutaneous injection. The primary end point of the study was change in the number of migraine days per month, assessed in the third month of treatment. The drug met the end point, reducing an average of 4.2 migraine days for those on the active drug versus 3 days for the placebo. (P = 0.0030).

In Goadbsy’s study of 163 patients, ALD403, a humanized peptide antibody to CGRP given intravenously one at the start of the trial, the primary end point was change from baseline in migraine days per month, measured in weeks 5 through 8. The average change from baseline in migraine days per month was a decline of 5.6 for the medication versus 4.6 for placebo.

Most notably, 16% of patients given ALD403 were migraine free the entire 12 weeks of the therapy period, versus none of the placebo patients.