Treatment with TEV-48125 may help relieve chronic migraine in as little as 3 to 7 days from first treatment, according to study results published in Neurology.
The experimental monoclonal antibody developed by Teva Pharmaceuticals may help significantly decrease the number of headache hours experienced by patients with chronic migraine, which is defined as headaches occurring at least 15 days per month.
The original randomized, placebo-controlled phase 2b study examined the effects of monthly injections of TEV-48125 675/225 mg or 900 mg vs placebo at 3 months. In this study, investigators reanalyzed data to examine the effects of treatment at earlier time points.
The study included 261 participants, of which 87 received a once-monthly injection of TEV-48125 675/225 mg, 85 received TEV-48125 900 mg, and 89 received placebo. Participants recorded their headaches through an electronic diary.
Response to treatment began occurring at day 7 for those receiving the 675/225 mg dose and day 3 for those receiving the 900 mg dose compared to placebo (7.3 hrs vs 1.6 hrs at 7 days, P= .048 and 3.1 hrs vs +.4 hrs at 3 days, P= .033, respectively). At one week, the average number of headache hours decreased by 9.1 hours for those receiving the lower dose, 11.4 hours for those receiving the higher dose, and 2.9 hours for those receiving placebo. The improvement in headache hours was sustained for both treatment groups through the second (P= .004 and P< .001) and third (P= .025 and P< .001) weeks of treatment and throughout the study (month 3, P= .0386 and P= .0057). By week 2, both doses promoted at least a moderate reduction in weekly headache days compared to placebo (P= .031 and P= .005).
“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,” said study author Marcelo Bigal, MD, PhD, of Teva Pharmaceuticals. “If these results can be confirmed with larger studies, this could be exciting for people with migraine.”