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- Title
Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Score Improvement in Japanese Patients with Episodic Migraine by Galcanezumab Treatment: Japan Phase 2 Study.
- Authors
Shibata, Mamoru; Nakamura, Tomomi; Ozeki, Akichika; Ueda, Kaname; Nichols, Russell M
- Abstract
Purpose: Evaluate changes from baseline in health-related quality of life (QoL) in Japanese patients with episodic migraine receiving preventive treatment with galcanezumab (GMB). Patients and Methods: Preventive treatments for migraine have been shown to improve QoL, but few clinical trials have examined QoL outcomes in Japanese patients. This phase 2, randomized, double-blind, placebo-controlled study was conducted at 40 centers in Japan. Patients aged 18– 65 years with episodic migraine (4– 14 monthly migraine headache days) received GMB 120 mg (n=115), 240 mg (n=114), or placebo (PBO, n=230) as monthly subcutaneous injections for 6 months. QoL was measured monthly using the Migraine-Specific Quality-of-Life Questionnaire (MSQ) version 2.1. Prespecified analyses were differences between GMB and PBO for change from baseline in all 3 domains of the MSQ and MSQ-Total, for each month and the average over Months 4– 6. Results: Treatment with GMB significantly increased MSQ scores from baseline vs PBO. Average change ± SE from baseline across Months 4– 6 was 10.12± 0.72 (PBO), 17.13± 1.03 (GMB 120 mg; P< 0.001), and 15.91± 1.03 (GMB 240 mg; P< 0.001) for MSQ Role Function-Restrictive; 4.80± 0.65 (PBO), 9.64± 0.93 (GMB 120 mg; P< 0.001), and 8.35± 0.93 (GMB 240 mg; P< 0.05) for MSQ Role Function-Preventive (MSQ-RFP); 3.46± 0.77 (PBO), 10.04± 1.10 (GMB 120 mg; P< 0.001), and 7.73± 1.10 (GMB 240 mg; P< 0.05) for MSQ Emotional Function, and 7.14± 0.67 (PBO), 13.46± 0.95 (GMB 120 mg; P< 0.001), and 11.98± 0.95 (GMB 240 mg; P< 0.001) for MSQ-Total. Significantly greater improvement in scores in all MSQ domains and MSQ-Total was observed for both GMB doses vs PBO at Month 1 and was maintained for Months 1– 6 (excluding Month 5 for MSQ-RFP). Conclusion: Preventive treatment with GMB 120 mg/240 mg improves MSQ scores in Japanese patients with episodic migraine. Improvements were seen within the first month and maintained for 6 months and are similar to those seen in global studies enrolling primarily Caucasian patients. Clinical Trial Registration: ClinicalTrials.gov, NCT02959177 (registered November 7, 2016).
- Subjects
JAPAN; JAPANESE people; CLINICAL trial registries; MIGRAINE; QUALITY of life; SUBCUTANEOUS injections
- Publication
Journal of Pain Research, 2020, Vol 13, p3531
- ISSN
1178-7090
- Publication type
Article
- DOI
10.2147/JPR.S287781