Phase III study of Emgality shows significant reduction in episodic cluster headache.- Eli Lilly.

Eli Lilly announced full results from a Phase III study of patients with episodic cluster headache treated with Emgality (galcanezumab-gnlm). In this study, patients with episodic cluster headache treated with Emgality (300 mg once-monthly) experienced statistically significant differences in the reduction of weekly cluster headache attacks compared to patients treated with placebo across Weeks 1 to 3 of the two-month, double-blind treatment period (-8.7 for Emgality compared to -5.2 for placebo, p=0.036), the primary endpoint of the study. Three out of four patients (76%) treated with Emgality (300 mg once-monthly) achieved at least a 50 percent reduction in weekly cluster headache attacks compared to 57 percent for placebo at Week 3 (p=0.04), the gated secondary endpoint. Additionally, 73 percent of patients treated with Emgality reported improvements based on the Patient Global Impression of Improvement (PGI-I) at Week 4, compared to 46 percent for placebo (p=0.016).

The observed safety and tolerability profile was consistent with previous studies that evaluated Emgality for the prevention of migraine. In this study, 8 percent of patients treated with Emgality discontinued treatment during the study compared to 21 percent of patients treated with placebo. Four percent of patients treated with Emgality discontinued treatment during the study due to adverse events compared to 2 percent of patients treated with placebo. Discontinuations due to lack of efficacy occurred in 2 percent of patients treated with Emgality, compared to 14 percent of patients treated with placebo (p=0.036). Detailed primary and secondary results will be presented at the American Headache Society (AHS) annual meeting.