Galcanezumab Significantly Reduces Migraine Headaches vs Placebo

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Participants were randomly assigned to receive either galcanezumab 5 mg, 50 mg, 120 mg, or 300 mg once a month or placebo for a 3-month duration.
Participants were randomly assigned to receive either galcanezumab 5 mg, 50 mg, 120 mg, or 300 mg once a month or placebo for a 3-month duration.

Monthly subcutaneous injections of galcanezumab at either 120 mg or 300 mg were effective for preventing migraines, according to results from a randomized clinical trial published in JAMA Neurology. These results support further testing in larger phase 3 clinical trials.

Galcanezumab (LY2951742), a monoclonal antibody against calcitonin gene-related peptide (CGRP), is one example of a novel class of medications for preventing migraine. To study whether at least 1 dose of galcanezumab would be superior to placebo at preventing migraine, researchers conducted a randomized clinical trial in the United States between July 7, 2014, and August 19, 2015, in 37 clinics (clinicaltrials.gov Identifier: NCT02163993).

Of 936 participants assessed, 410 met the entry criteria (18-65 years old; 4-14 migraine headache days per month; migraine onset before age 50). Participants were randomly assigned to receive either galcanezumab or placebo in doses of 5 mg, 50 mg, 120 mg, or 300 mg once a month during the 3 months of treatment.

Mean change from baseline of the number of migraine headache days was measured 9 to 12 weeks after participants were randomly assigned.

Galcanezumab at 120 mg significantly reduced migraine headache days compared with placebo (99.6% posterior probability -4.8 days; 90% Bayesian credible interval, -5.4 to -4.2 days vs 95% superiority threshold [Bayesian analysis] -3.7 days; 90% Bayesian credible interval, -4.1 to -3.2 days).

Adverse events that were reported by 5% or more of patients in at least 1 galcanezumab dose group, and more frequently than in the placebo groups, included injection-site pain, upper respiratory tract infection, nasopharyngitis, dysmenorrhea, and nausea.

Limitations of the study include its relatively short duration, and a baseline period of 28 days, which may not have been long enough to establish an accurate baseline of headache frequency.

“Physicians and patients are seeking more effective and better tolerated treatments for migraine prevention than those currently approved and prescribed,” the researchers wrote. “These results provided sufficient efficacy, tolerability, and safety data to justify further development of galcanezumab, 120 mg and 240 mg, in larger phase 3 clinical trials.”

Please refer to the original article for disclosure information.

Funding/Support: This study was sponsored and funded by Eli Lilly and Company, who also provided the study drug.

Reference

Skljarevski V, Oakes TM, Zhang Q, et al. Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial [published online December 18, 2017]. JAMA Neurol. doi:10.1001/jamaneurol.2017.3859

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