Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN)

Purpose To evaluate secondary outcomes including changes in functioning and disability associated with galcanezumab, a humanized monoclonal antibody to calcitonin gene-related peptide, in patients with chronic migraine. Methods Patients randomly received galcanezumab (120 mg n  = 278, 240 mg n  = 27...

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Bibliographic Details
Published in:Quality of life research 2021-01, Vol.30 (1), p.105-115
Main Authors: Ford, Janet, Tassorelli, Cristina, Leroux, Elizabeth, Wang, Shufang, Ayer, David, Nichols, Russell, Detke, Holland
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Analysis of covariance
Antibodies, Monoclonal, Humanized - pharmacology
Antibodies, Monoclonal, Humanized - therapeutic use
Chronic Disease
Clinical significance
Clinical trials
Double-Blind Method
Double-blind studies
Female
Humans
Male
Medicine
Medicine & Public Health
Middle Aged
Migraine
Migraine Disorders - drug therapy
Migraine Disorders - prevention & control
NCT
NCT02614261
Patients
Public Health
Quality of Life - psychology
Quality of Life Research
Sociology
Surveys and Questionnaires
Treatment Outcome
Young Adult
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Summary:Purpose To evaluate secondary outcomes including changes in functioning and disability associated with galcanezumab, a humanized monoclonal antibody to calcitonin gene-related peptide, in patients with chronic migraine. Methods Patients randomly received galcanezumab (120 mg n  = 278, 240 mg n  = 277) or placebo ( n  = 558) during 3 months of double-blind treatment, followed by a 9-month open-label extension. The Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQv2.1) measured the impact of migraine on patient functioning. The Migraine Disability Assessment (MIDAS) quantified headache-related disability. Changes from baseline were analyzed with mixed model repeated measures or analysis of covariance. Results Total MSQ score at baseline was 44.88 ± 18.02 (mean ± SD), indicating significant functional impairment. At Month 3, least squares (LS) mean change ± SE in total MSQ for galcanezumab-treated patients were 20.51 ± 1.49 (120 mg) and 20.49 ± 1.49 (240 mg), both statistically significantly greater vs placebo-treated patients (14.55 ± 1.21; both P  
ISSN:0962-9343
1573-2649
DOI:10.1007/s11136-020-02623-1