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New Drugs Offer Hope for Migraine Prevention

Monoclonal antibodies target calcitonin gene-related peptide

Two mid-stage trials may offer hope for people with migraine, according to the American Academy of Neurology (AAN). The new studies, released April 22, will be presented at the AAN’s 66th Annual Meeting, which is scheduled to take place April 26 to May 3 in Philadelphia, Pennsylvania.

Both phase II trials involved drugs aimed at preventing migraine attacks from occurring, rather than stopping the attacks once they have started. The studies are the first to test monoclonal antibodies for the prevention of migraine. Both antibodies — ALD403 (Alder Biopharmaceuticals) and LY2951742 (Arteaus) — are directed against a relatively new target in migraine prevention, the calcitonin gene-related peptide (CGRP).

The first study involved 163 people who experienced migraine from 5 to 14 days per month. They received either a single intravenous dose of the monoclonal antibody ALD403 or placebo and were followed for 24 weeks. Those who received the active treatment had an average of 5.6 fewer migraine days per month (a 66% decrease) compared with 4.6 fewer days per month for those who received placebo (a 52% decrease). Sixteen percent of those who were treated with ALD403 had no migraine days at 12 weeks, whereas none of those who received placebo were free from migraine at that time point.

There were no differences in side effects between those receiving ALD403 and those receiving placebo.

In the second study, 217 people who experienced migraine 4 to 14 days per month received biweekly subcutaneous injections of either the monoclonal antibody LY2951742 or placebo for 12 weeks.

Those who received the active treatment had an average of 4.2 fewer migraine days per month at 12 weeks (a 63% decrease), whereas those who received placebo had 3.0 fewer migraine days per month (a 42% decrease). Patients who received the antibody were more likely to experience adverse effects, including injection-site pain, upper respiratory tract infections, and abdominal pain. Nevertheless, the active treatment was considered to be safe and well-tolerated.

“We’re cautiously optimistic that a new era of mechanism-based migraine prevention is beginning,” said co-author David Dodick, MD.

Source: AAN; April 22, 2014.

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