Galcanezumab scores in prevention of episodic cluster headache

US pharma major Eli Lilly (NYSE: LLY) says that its drug candidate galcanezumab met its primary endpoint in a Phase III study of patients with episodic cluster headache, demonstrating statistically-significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period.

A statistically-significantly greater percentage of patients treated with galcanezumab also achieved at least a 50% reduction in weekly cluster headache attacks compared to placebo at Week 3, the gated secondary endpoint.

The observed safety and tolerability profile was consistent with previous studies that evaluated galcanezumab for the prevention of migraine. In this study, 8% of patients treated with galcanezumab discontinued treatment during the study compared to 21% of patients treated with placebo. 4% of patients treated with galcanezumab discontinued treatment during the study due to adverse events compared to 2% of patients treated with placebo. Discontinuations due to lack of efficacy occurred in 2% of patients treated with galcanezumab, compared to 14% of patients treated with placebo.