Peter J. Goadsby, M.D., Ph.D., from King’s College London, and colleagues enrolled patients who had at least one attack every other day, a total of at least four attacks, or no more than eight attacks per day during a baseline assessment. Recruitment was halted before the planned sample size of 162 patients was reached because too few volunteers met the eligibility criteria; a total of 106 patients were enrolled and randomly assigned to receive either galcanezumab (300 mg) or placebo (49 and 57 patients, respectively), administered subcutaneously at baseline and one month.

The researchers found that the mean reduction in the weekly frequency of cluster headache attacks across weeks 1 through 3 was 8.7 and 5.2 attacks in the galcanezumab and placebo groups, respectively (difference, 3.5 attacks per week; 95 percent confidence interval, 0.2 to 6.7; P = 0.04). The percentage of patients with a reduction of at least 50 percent in headache frequency at week 3 was 71 and 53 percent in the galcanezumab and placebo groups, respectively (P = 0.046). With the exception of injection-site pain, experienced by 8 percent of patients in the galcanezumab group, no substantial between-group differences were seen in the incidence of adverse events.

“Longer and larger trials are required in order to determine the durability and safety of this medication,” the authors write.

The study was funded by Eli Lilly, the manufacturer of galcanezumab.

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