Measures of functioning using MSQ v2.1 in patients with a history of episodic migraine and treated with galcanezumab or placebo injections in a Phase 2 clinical trial (P2.179)

Objective: To evaluate changes from baseline to 12-week endpoint of two patient-reported disease-specific measures of functioning in adult patients with migraine treated with galcanezumab or placebo. Background: Migraine is a chronic neurological disease that significantly impacts one’s ability to perform daily activities. Galcanezumab is a humanized monoclonal antibody that selectively binds to and blocks physiological activity of calcitonin gene-related peptide (CGRP). Design/Methods: Male and female patients aged 18 to 65 years with a history of episodic migraine including 4 to 14 migraine headache days (MHD) and at least 2 migraine attacks per 28-day period were randomized. Galcanezumab (subcutaneous [SC] injection; 5, 50, 120, or 300 mg) or placebo (SC injection; 0.9% sodium chloride, USP; volume matched) was administered every 28 days for 12 weeks. Post-hoc analysis of the Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Headache Impact Test (HIT-6™) was performed using only the 120-mg arm (n=60) vs placebo (n=127). Results: At baseline, MHD (average=6.69) did not correlate with HIT-6 or MSQ total scores, but did correlate with MSQ Role Function-Preventive (RFP; p=0.0246). MHD (average=2.76) correlated with HIT-6 and MSQ scores at 12 weeks following treatment (120-mg arm and placebo; all p Conclusions: Galcanezumab demonstrated significant improvements in functioning compared with placebo. Only one MSQ domain (RFP) correlated with number of MHD at baseline; however, all three MSQ domains were highly correlated with number of MHD post-treatment. Disclosure: Dr. Ford has received personal compensation for activities with Eli Lily and Company as an employee. Dr. Ford has stock and/or stock options in Eli Lily and Company. Dr. Ayer holds stock and/or stock options in Eli Lilly. Dr. Nyhuis has received personal compensation for activities with Eli Lilly and Company. Dr. Aurora has received personal compensation for activities with Eli Lilly and Company as an employee and Allergan as a consultant. Dr. Aurora hold stock and/or stock options in Lilly and Company. Dr. Carter has received personal compensation for activities with Eli Lilly and Company as an employee. Dr. Carter holds stock and/or stock options in Eli Lilly and Company.