ArticleNeurology and therapy2023
Galcanezumab Efficacy Through the Dosing Interval in Japanese Patients with Episodic Migraine: Post Hoc Analysis of a Phase 2 Randomized Trial.
Article in Neurology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02959177 (A Randomized, Double-Blind, Placebo-Controlled Study of LY2951742), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 (Galcanezumab) in Japanese Patients With Episodic Migraine
Who cites it
1 citing paper in PubMed, 18 citations in OpenAlex.
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe efficacy and safety of galcanezumab as a preventive treatment in Japanese patients with episodic migraine was demonstrated in a phase 2, randomized, placebo-controlled trial (conducted December 2016-January 2019). This post hoc analysis assessed the consistency of galcanezumab efficacy through the monthly dosing interval.
methodsPatients with 4-14 migraine headache days/month were randomized (2:1:1, stratified by baseline migraine frequency) to subcutaneous placebo (n = 230), 120-mg galcanezumab (with 240-mg loading dose; n = 115) or 240-mg galcanezumab (n = 114) once monthly for 6 months. Outcomes included change from baseline in weekly migraine headache days, proportion of patients with migraine headache on each day, and proportion of patients with worsening migraine headache days during each month ([average of weeks 3-4] - [average of weeks 1-2] > 0).
resultsIn the 120-mg (approved dose) galcanezumab group, mean change from baseline in weekly migraine headache days was consistent and significantly greater (p < 0.05) than placebo for weeks 1-4; efficacy was consistent when averaged across months 1-6 and in most individual months. Averaged across months 1-6, the proportion of patients with migraine headache was significantly lower with galcanezumab than placebo on every day in both dose groups and was not significantly different between days 2 and 28 with 120-mg galcanezumab (p = 0.161). Within each month, the proportion of patients with migraine headache was generally consistent from days 2-28. The proportion of patients with worsening during the dosing interval did not significantly exceed 50% in any group during any month.
conclusionsThis post hoc analysis supports the consistency of efficacy of galcanezumab across 6 months of treatment and suggests that wearing-off within the dosing interval does not occur on a population level in Japanese patients with episodic migraine.
trial registrationClinicalTrials.gov identifier, NCT02959177.
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