Measures of Functioning in Patients With Episodic Migraine

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Measures of Functioning in Patients With Episodic Migraine
Key Take-Away: 

Migraine is a chronic, prevalent, and multifactorial neurovascular disorder that leads to severe functional disability. Galcanezumab is an effective medication that can prevent the development of migraine and the study validate the Galcanezumab impact among episodic migraineurs by diagnosing the changes in two disease-specific patient-reported outcomes after 12-week treatment.


Headache‐associated functional impairment management is a primary goal for PROs and migraine preventive treatment. Recognizing which medications can enhance patient functioning along with managing migraine headaches is important for reducing the patient burden. This Phase 2b double‐blind, randomized, placebo‐controlled study aimed to assess 12‐week changes in two disease‐specific patient‐reported outcomes (PRO) measures among migraineurs treated with placebo or Galcanezumab.



The patients administered with 120 mg subcutaneous injection of Galcanezumab or placebo every 28 days for 12 weeks. Patients who completed 12 weeks of treatment on 2 PROs and Migraine‐Specific Quality of Life Questionnaire (MSQ) v2.1) were analyzed for post hoc secondary analyses.



Analysis of covariance reported considerable variations in the least square mean changes from baseline between Galcanezumab and placebo for all MSQ domains including Role Function‐Restrictive mean change placebo of 22.40, Galcanezumab of 31.92; total mean change placebo of 18.63, Galcanezumab of 27.36; Emotional Function mean change placebo of 16.88, Galcanezumab of 26.61, and Role Function‐Preventive mean change placebo of 13.43, Galcanezumab of 19.76. The MSQ total scores or HIT‐6 showed association with the mean number of migraine headache days (MHDs) at the 12 weeks post‐treatment. Change in MSQ domains and difference in HIT‐6 scores was correlated with change in MHD.



The Galcanezumab showed considerable functional improvements as indicated by changes in MSQ scores when compared to placebo. Change in MHD was associated with reductions in HIT‐6 scores and improvements in MSQ, showing the clinical significance of these changes related to PROs that estimated function.



Link to the source:

Original title of the article:

Measures of Functioning in Patients With Episodic Migraine: Findings From a Double-Blind, Randomized, Placebo-Controlled Phase 2b Trial With Galcanezumab.


David W. Ayer et al.

Therapeutic, Galcanezumab, Episodic Migraine, Head, Monoclonal Antibody, Double-Blind, Randomized, Placebo-Controlled Phase 2b Trial, Efficacy, HIT‐6, MSQ
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