Objective - To evaluate 12-week changes from baseline of 2 disease-specific 
patient-reported outcome (PRO) measures in adults with migraine treated with 
galcanezumab, an investigational humanized antibody binding calcitonin 
gene-related peptide (CGRP), or placebo. Background - Preventing 
headache-related functional impairment is an important goal of migraine 
preventive treatment and a measurement target for PROs. Understanding which 
drugs have the potential to improve patient functioning in addition to 
preventing migraine headaches is vital to lessening patient burden. 
Design/Methods - This Phase 2b double-blind, randomized, placebo-controlled 
study enrolled adults with episodic migraine. Galcanezumab (120 mg subcutaneous 
injection; n = 60) or placebo (n = 127) was administered every 28 days for 12 
weeks. Post hoc secondary analyses were conducted for those who completed 12 
weeks of treatment on 2 PROs: The Migraine-Specific Quality of Life 
Questionnaire (MSQ) v2.1 and the Headache Impact Test™ (HIT-6). Results - 
Analysis of covariance revealed significant differences in least square mean 
changes from baseline between galcanezumab and placebo for all MSQ domains 
including total mean change placebo of 18.63, galcanezumab of 27.36 (95% CI 
2.449, 15.008; P-value of .0067); Role Function-Restrictive mean change placebo 
of 22.40, galcanezumab of 31.92 (95% CI 2.636, 16.518; P-value of .0071); Role 
Function-Preventive mean change placebo of 13.43, galcanezumab of 19.76 (95% CI 
0.476, 12.185; P-value of .0342); and Emotional Function mean change placebo of 
16.88, galcanezumab of 26.61 (95% CI 2.789, 16.674; P-value of .0063). At 
baseline, mean number of migraine headache days (MHDs) did not correlate with 
MSQ total scores or HIT-6. At 12 weeks post-treatment, MHD correlated with MSQ 
and HIT-6 scores (all P < .0001). Change in MHD was associated with change in 
MSQ domains and change in HIT-6 scores (all P < .0001). Conclusions - In 
comparison with placebo, treatment with galcanezumab was associated with 
significant functional improvements as reflected by changes in MSQ scores. 
Change in MHD was associated with improvements in MSQ and reductions in HIT-6 
scores, indicating the clinical importance of these changes in relation to PROs 
that measure function.