Clinical Data
The episodic cluster headache study included a two-month treatment period comparing galcanezumab to placebo. Patients with episodic cluster headache treated with galcanezumab (300 mg once-monthly) experienced statistically significant differences in the reduction of weekly cluster headache attacks compared to patients treated with placebo across weeks one to three of the two-month, double-blind treatment period (-8.7 for galcanezumab compared to -5.2 for placebo, p=0.036), the primary endpoint of the study.In May 2017, Lilly announced positive data from three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) evaluating galcanezumab for the treatment of chronic and episodic migraine. In these studies, galcanezumab demonstrated statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses (120 mg and 240 mg once-monthly).