HealthDay News — For patients with episodic migraine, galcanezumab is better than placebo for reducing migraine headache days, according to a study published online May 29 in JAMA Neurology.
Virginia L. Stauffer, PharmD, from Eli Lilly and Co. in Indianapolis, and colleagues conducted a randomized trial comparing galcanezumab (120 and 240mg) with placebo for prevention of episodic migraine with or without aura. A total of 858 adults with at least a 1-year history of migraine, 4 to 14 migraine headache days per month, and a mean of at least 2 migraine attacks per month within the past 3 months received once-monthly treatments for 6 months and were followed up for 5 months after the last injection.
The researchers found that the primary objective of an overall mean change from baseline in the number of monthly migraine headache days during the treatment period was achieved for both galcanezumab doses; treatment was correlated with significant reductions of 4.7 and 4.6 days (120 and 240mg, respectively) compared with 2.8 days for placebo. After multiplicity adjustment, all key secondary objectives were also significant. On measures of efficacy there were no meaningful differences between the 120- and 240mg doses of galcanezumab. High completion rate during treatment was observed (81.9%). Across treatment groups, the incidence of discontinuation owing to adverse events was less than 5%.
“Galcanezumab 120mg and 240mg monthly injections provided clinical benefits and improved functioning,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly, which manufactures galcanezumab and funded the study.
The Food and Drug Administration (FDA) is currently reviewing galcanezumab for the prevention of migraines in adults with a decision expected in the third quarter of 2018.