Oskar Hansson, MD, PhD
Data from an 8-week double-blind trial of galcanezumab (Emgality, Eli Lilly) in patients with cluster headache demonstrate good efficacy and safety, with patients reporting a significant reduction in weekly cluster headache attack frequency at week 3.

The humanized monoclonal antibody against calcitonin gene-related peptide was recently approved in September 2018 for the prevention of migraine in adults. These data on cluster headache were presented at the 2019 American Academy of Neurology Annual Meeting, May 4-10 in Philadelphia.

The 4-period study was led by Jennifer N. Bardos, PharmD, a senior clinical research scientist with Eli Lilly and Company, who sponsored the study, and included a screening, baseline, 8-week treatment, and washout period.

In the double-blind, placebo-controlled treatment period, 49 patients with episodic cluster headache were randomly assigned to receive galcanezumab 300 mg and 57 patients received placebo subcutaneously once monthly.

The primary efficacy endpoint was overall mean change from baseline in weekly frequency of cluster headache attack between weeks 1 through 3. The main secondary endpoint was the proportion of patients who experienced at least a 50% reduction in weekly cluster headache attack frequency from baseline to week 3.

The investigators reported a mean change in weekly cluster headache attack frequency of -8.7 from weeks 1 through 3 in patients who received galcanezumab vs -5.2 for those in the placebo group (treatment groups difference in mean change, -3.5; 95% CI, -6.7 to -0.2; P =.036).

At week 3, 76% of patients in the treatment group achieved at least a 50% reduction in weekly cluster headache attack frequency versus 57% of patients in the placebo group (P =.04).

Notably, 4 participants in the treatment group discontinued treatment compared with 12 in the placebo group, 1 and 8 of which was due to lack of efficacy, respectively. The investigators observed no clinically meaningful differences between the 2 groups in terms of safety or tolerability besides a greater incidence of injection site pain in patients who received galcanezumab versus placebo (8.2% vs 0%; P =.043).

The results are promising for patients with cluster headache who have very few effective treatments available to them. Recently, Teva Pharmaceuticals announced the discontinuation of its clinical development program for fremanezumab for the treatment of episodic cluster headache, after a phase 3 futility analysis indicated that the primary efficacy endpoint was unlikely to be met.

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Bardos JN, Goadsby PJ, Dodick D, et al. A placebo-controlled study of galcanezumab in patients with episodic cluster headache: results from the 8-week double-blind treatment phase. Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, PA.