Eli Lilly announced positive results from a Phase 3 trial which investigated galcanezumab in the treatment of episodic cluster headaches. Galcanezumab, an investigational once-monthly, self-administered injection, is a monoclonal antibody designed to bind and inhibit the activity of calcitonin gene-related peptide (CGRP). 

The episodic cluster headache trial included a total of 106 patients with an average of 17.5 cluster headache attacks per week at baseline. Patients were randomized to either once-monthly galcanezumab 300mg administered subcutaneously or placebo. 

Results showed that across Weeks 1 to 3 of the 2-month study period, the galcanezumab group saw a statistically significant difference in the reduction of weekly cluster headache attacks compared with placebo (primary endpoint) (-8.7 for galcanezumab vs -5.2 for placebo; P=.036). With regard to the secondary endpoint, a statistically significantly greater percentage of patients in the galcanezumab group achieved ≥50% reduction in weekly cluster headache attacks compared with placebo at Week 3.

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Safety findings were consistent with previous studies of galcanezumab. Eight percent of the treatment group and 21% of the placebo group discontinued treatment during 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.

For more information visit Lilly.com.

that their investigational migraine and cluster headache treatment, galcanezumab, met the primary endpoint of significant reduction in weekly cluster headache attacks compared to those treated with placebo.