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The placebo-controlled phase 2b trial with Galcanezumab
found its clinical relevance in improving the patient-related outcomes in
chronic migraine.
According to a Double‐Blind, Randomized,
Placebo‐Controlled Phase 2b Trial the Galcanezumad, humanised monoclonal
antibody showed significant improvements in severe migraine. The study involved
the evaluation of two disease-specific patient-reported outcomes (PRO)
measurement among adults at 12 weeks from the baseline. The primary goal of a
migraine preventive treatment and a measurement target for PROs was the
prevention of headache-related functional impairment. Identification of which
drug manage a migraine headache along with improving patient functioning is
essential to reduce the patient burden.
Patients received 120 mg Galcanezumab subcutaneously or
placebo for 28 days up to 12 weeks. The patients who completed the 12 weeks of
treatment on two PROs [HIT‐6(Headache Impact Test™) and MSQ (Migraine‐Specific
Quality of Life Questionnaire)] went through post hoc secondary analyses.
Analysis of covariance exhibited considerable
variations in the least square mean changes between Galcanezumab and placebo
from baseline for all MSQ domains. The total mean change noticed for placebo
was of 18.63 and for Galcanezumab of 27.36 (P‐value of .0067). Emotional
Function mean the shift in placebo was 16.88 and Galcanezumab was 26.61
(P‐value of .0063). Role Function‐Preventive mean change noticed for placebo
was 13.43 and for Galcanezumab was 19.76 (P‐value of) and the Role
Function‐Restrictive mean change for placebo was 22.40 and for Galcanezumab was
31.92 (P‐value of 0.0342 and 0.0071,
respectively). The MSQ total scores and HIT-6 was not associated with migraine
headache days (MHDs) at the baseline. The association was noticed between MSQ
and HIT‐6 scores with MHD at 12 weeks post‐treatment (all P < .0001).
As reflected by changes in MSQ scores, the treatment with
Galcanezumab shows significant functional improvements as compared to placebo.
The increase in MSQ and decrease in HIT-6 scores is associated with clinically
important MHD changes relating to PROs.
Headache
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.
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