Galcanezumab has shown efficacy in safely reducing the number of monthly migraine headache days in individuals with migraine, according to a study published in Cephalalgia.
This global, double-blind, 6-month study (ClinicalTrials.gov identifier: NCT02614196) included 915 subjects who were randomly assigned to receive monthly doses of subcutaneously administered galcanezumab 120 mg (n=231), galcanezumab 240 mg (n=223), or placebo (n=461). Study participants receiving galcanezumab 120 mg and 240 mg saw a mean reductions of 4.3 days and 4.2 days in monthly migraine headache days, respectively (an additional 2.0-day and 1.9-day reduction compared with placebo, respectively; 95% CI, 2.6 to 1.5 and 2.4 to 1.4, respectively).
Adverse events mainly consisted of injection site pain, which occurred significantly more in patients receiving galcanezumab vs placebo. Injection site erythema was much more common in the galcanezumab 240 mg group compared with placebo. Limitations on this study include restrictive criteria for inclusion that preclude result generalizability.
The study researchers conclude that “[galcanezumab] treatment was associated with a statistically significant and clinically meaningful reduction in monthly [migraine headache days] at doses of 120 and 240 mg given subcutaneously once monthly. Moreover, patients treated with either dose of galcanezumab reported a reduction in the migraine-related impairment of function and a significant reduction in migraine-related disability, while also reducing the use of acute migraine medications.”
This study was funded by Eli Lilly and Company.
Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 Phase 3 randomized controlled clinical trial [published online May 31, 2018]. Cephalalgia. doi: 10.1177/0333102418779543