Trial Shows Antibody Reduces Days with Migraines

(R. Nial Bradshaw, Flickr)

15 May 2015. A clinical trial shows high doses of an engineered antibody reduced the number of days per month that people with a history of migraines experience migraine episodes. First findings from the intermediate-stage trial of the antibody code-named AMG334 by the biotechnology company Amgen were reported at a meeting of the International Headache Society now underway in Valencia, Spain.

Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. Migraine Foundation says the syndrome is one of the top 20 disabling disorders and estimates some 36 million people suffer migraines in the U.S., including 14 million who experience migraines nearly every day or more often.

The clinical trial evaluated Amgen’s antibody AMG334 designed to prevent migraines by limiting receptors for calcitonin gene-related peptide. This peptide and its receptors are expressed in a number of different cells throughout the central and peripheral nervous systems, and regulate inflammation and pain arising from the stimulation of nerve cells. AMG334 acts by inhibiting the peptide’s receptors, not the peptide itself, and is administered monthly by injections under the skin.

The trial tested AMG334 in three dosage levels — 7, 21, and 70 milligrams — against a placebo, among 483 individuals with a history of migraines, recruited at 66 sites in the U.S., Canada, and Europe. The study looked primarily at the number of days participants experienced migraines in the last 4 weeks of a 12-week treatment period, compared to a baseline period before treatments.

Participants overall reported an average baseline of 8.7 days per month where they experienced migraines. Amgen says recipients of the highest doses, 70 milligrams, of AMG334, experience 3.4 fewer days per month with migraines compared to 2.3 fewer days for those taking the placebo, a statistically reliable difference. The company did not report findings for intermediate or low-dose recipients.

Amgen also reports the highest dose recipients experience fewer days per month with headaches of any kind, as well as fewer days per month when they need to take migraine medication, compared to placebo recipients. The company says participants taking AMG334 and the placebo experienced similar side effects: influenza, fatigue, common cold, joint pain, and back pain. No life-threatening adverse events or deaths were reported.

Read more:

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• Zymeworks, Celgene to Develop Double-Binding Antibodies
• Trial Shows Engineered Antibody Relieves Psoriasis
• Early Clinical Trial to Test Leukemia Antibody Safety

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