To assess efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in adult patients with episodic migraine.

Migraine is a neurological disorder with high disease burden and unmet clinical need.

This was a phase 3, double-blind (DB), randomized, placebo-controlled, 3-month study with a 3-month open-label extension (OLE). Eligible patients with episodic migraine were randomized to monthly subcutaneous injections of placebo (N=259) or galcanezumab 120mg with a 240mg loading dose (N=261). Patients entering OLE received galcanezumab 120mg/month. Efficacy measures included number of monthly migraine headache days (MHDs), ≥50% reduction in monthly MHDs, and Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive (MSQ-RFR) domain score. Change from baseline in continuous and categorical measures was analyzed using mixed model repeated measures analysis and generalized linear mixed models, respectively. OLE results are reported by prior DB treatment assignment.

Of the patients who completed DB treatment, 484 (99.4%) entered OLE, with 96.3% completing Month 6. From a baseline of 8.23 monthly MHDs at the beginning of DB, patients at month 6 in the prior placebo and galcanezumab groups had a mean change of -4.56 and -4.62, respectively. At Month 6, the percentage of patients with ≥50% response was 67.2% and 70.9%, respectively. Of the 142 galcanezumab-treated patients with ≥50% response at Month 3, 66.2% maintained that response throughout OLE. At Month 6, patient functioning on the 100-point MSQ-RFR increased from baseline by 24.9 and 23.7 points, respectively. The common (>2%) treatment-emergent adverse events were injection site reaction (3.3%), upper respiratory tract infection (2.7%), and injection site pruritus (2.5%) during the OLE. Three patients (0.6%) discontinued due to an adverse event. There were no clinically meaningful changes in any safety parameters.