Antibody Treatment Shown to Prevent Migraine

(geralt, Pixabay)

9 June 2016. A clinical trial shows an engineered antibody in one week reduced the number of headaches in people who experienced migraines for an average of 18 years. Results of the study testing the experimental treatment appear in yesterday’s issue of the journal Neurology, published by American Academy of Neurology.

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 tested a new engineered antibody now code-named TEV-48125 by Teva Pharmaceuticals, an Israeli company with offices in Frazer, Pennsylvania. TEV-48125 is designed to block the actions of calcitonin gene-related peptide, amino acids stimulating inflammation in nerve cells associated with migraine. Teva formulates TEV-48125 as an injection to prevent migraines for people with the disorder.

The study, an intermediate-stage clinical trial, tested two dosage strategies with TEV-48125. Some 261 people at 56 sites in the U.S. experiencing chronic migraines for an average of 18 years took part in the trial, reporting 22 days and 162 hours with headaches each month. Participants were randomly assigned to first receive a once-a-month injection of TEV-48125 in a higher dose (900 milligrams) or lower dose (675 milligrams) followed by a 225 milligram maintenance injections in the second and third months. A third group received placebo injections.

The researchers led by Teva’s Marcelo Bigal looked primarily at the number of hours and days a month participants experienced headaches, recorded in an electronic diary. One week after the treatment, individuals taking the higher dose of TEV-48125 reported having 11 fewer hours of headaches, while lower-dose recipients were having 9 fewer headache hours, compared to 3 fewer hours of headaches reported by placebo recipients. After 2 weeks, higher-dose recipients reported 1.5 fewer days with headaches, with lower-dose participants reporting a similar 1.3 fewer headache days, and placebo recipients reporting 0.8 fewer days.

The most common adverse effects, reported in an earlier article, were mild injection site pain and itching. Four participants experienced serious adverse events, not related to the treatments.

Many participants receiving TEV-48125 in the higher dose said they started experiencing fewer headaches as soon as 3 days after the injection. Bigal, the study’s first author, says in an American Academy of Neurology statement this is a key finding. “Most people who receive preventive medication for chronic migraine stop using them,” he notes, “and one reason for that is the drugs can take a long time to become effective. If these results can be confirmed with larger studies, this could be exciting for people with migraine.”

Read more:

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• Vibration Technology Developed to Diagnose Back Pain
• Pain Medication Given FDA Breakthrough Tag
• FDA Approves Nasal Spray Migraine Therapy
• University Spin-Off Develops Pain Killer Patch

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