Two experimental drugs may offer hope for people with migraine. Two small studies of the drugs, which are aimed at preventing headaches rather than stopping them once they have started, show they reduced the frequency of headaches in migraine sufferers. The researchers say larger trials are now needed to confirm the findings.
Dr. Peter Goadsby, a professor in the department of clinical neuroscience at King’s College London, and also of the University of California San Francisco, was an author on both studies. He says the results “may potentially represent a new era in preventive therapy for migraine.”
Dr. David Dodick, of the Mayo Clinic in Arizona, was also an author on both studies. He says there is a “huge treatment need for migraine – the third most common and seventh most disabling medical disorder in the world,” and yet it remains poorly treated. There are “few effective and well tolerated treatments approved that prevent attacks from occurring,” he comments.
The two studies are the first to trial monoclonal antibodies – essentially lots of copies of one type of antibody – for the prevention of migraine. The antibodies target the calcitonin gene-related peptide, or CGRP.
CGRP – a protein produced by neurons – is thought to be important in migraine, but the two drugs tested in these studies are the first to target it specifically.
The results will be presented at the 66th Annual Meeting of the American Academy of Neurology, which takes place April 26th to May 3rd in Philadelphia, PA.
As both studies are phase II studies, designed to see if the treatments work well enough, larger studies are now needed to confirm the results, say the researchers.
In one study, which tested a drug called ALD403, the researchers enrolled 163 migraine sufferers who had migraines on 5 to 14 days per month. The patients received either a single IV dose of the drug or a placebo.
After a 24-week follow-up, the patients who had received the drug were, on average, getting migraines on 5.6 fewer days per month (a decrease of 66%), compared with 4.6 days per month (52% decrease) for those on placebo.
In the second study, which tested a drug called LY2951742, 217 people who had migraine on 4 to 14 days per month received biweekly injections of either the drug or a placebo for 12 weeks.
At the end of the 12 weeks, those who received the drug were getting on average 4.2 fewer migraine headaches a month (63% decrease), while the placebo group had 3 fewer migraine days per month (42% decrease).
Dr. Dodick told the Los Angeles Times that it is not unusual to see high rates in the placebo group in studies of pain. Part of the explanation is the high level of anticipation participants have of treatment success. And sometimes the invasiveness of the treatment can be a factor, as in this case (injections and infusions versus pills, for example). He says they will have to get a “grip on this” and carefully design the next phase of testing.
Speaking of the significance of the present study’s results, he says they are “cautiously optimistic that a new era of mechanism-based migraine prevention is beginning.”
Alder Biopharmaceuticals funded the ALD403 study, while Arteaus funded the LY2951742 study.
Meanwhile, in March 2014, Medical News Today recently learned that the US Food and Drug Administration has approved the marketing of a headband device for preventing migraine headaches. The headband delivers nerve-stimulating pulses and is intended for patients who cannot tolerate current migraine drugs.