A new drug to prevent migraine was associated with fewer headache hours for people with chronic migraine within three to seven days after the first injection, according to a study published online in Neurology, the medical journal of the American Academy of Neurology. Chronic migraine is defined as headaches occurring at least 15 days per month. Study participants had migraine attacks for an average of 20 years prior to treatment.
"Chronic migraine affects about 1 percent of all adults, yet less than 5 percent of those people receive a correct diagnosis and appropriate treatment," said study author Marcelo Bigal, MD, PhD, of Teva Pharmaceuticals in Frazer, Penn., which developed the new drug, called TEV-48125. "Most people who receive preventive medication for chronic migraine stop using them, 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."
TEV-48125 is an antibody that blocks the calcitonin gene-related peptide that plays a role in migraine pain. The study involved 261 people who had migraine for an average of 18 years. They had an average of 162 hours of headaches a month and an average of 22 days with headache per month.
Of the participants, 87 people received a monthly shot for three months with a low dose of the drug, 85 people received a high dose and 89 people received a placebo shot. The participants used an electronic diary to record their headaches. The phase 2b study was conducted to look for the results after three months, and the positive results were published. For this study, the researchers reanalyzed the results to look at the results on headache hours and days in the first days and weeks of the study.
After one week, the average number of headache hours went down by 2.9 hours for people taking the placebo, 9.1 hours for people taking the low dose of TEV-48125 and 11.4 hours for those taking the high dose. The higher dose first showed a difference from the placebo after three days, with 3.1 fewer headache hours, compared to an additional 0.4 hours for the placebo. The lower dose showed a difference from the placebo after seven days, with 7.3 fewer headache hours, compared to 1.6 fewer hours for the placebo.
For the number of days with moderate or severe headaches, both doses showed a difference from placebo after two weeks of treatment, with headaches reduced by 0.8 days for placebo, 1.3 days for the low dose and 1.5 days for the high dose.
Bigal noted that study limitations include that the analyses for the early results were not defined before the study was conducted and that study participants were not asked whether the results in the first days of the study were large enough to be meaningful for them.
The study was supported by Teva Pharmaceuticals.
Article: TEV-48125 for the preventive treatment of chronic migraine, Marcelo E. Bigal, MD, PhD, David W. Dodick, MD, Abouch V. Krymchantowski, MD, PhD, Juliana H. VanderPluym, MD, Stewart J. Tepper, MD, Ernesto Aycardi, MD, Pippa S. Loupe, PhD, Yuju Ma, MS and Peter J. Goadsby, MD, Neurology, doi: 10.1212/WNL.0000000000002801, published online 8 June 2016.