Evidence map›Paper›PMID 31004075›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2019

Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis.

Peter J Goadsby, David W Dodick, James M Martinez, Margaret B Ferguson, Tina M Oakes, Qi Zhang, Vladimir Skljarevski, Sheena K Aurora

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01625988 (A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01625988 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2013Enrolled218ConditionsMigraine HeadacheArmsLY2951742, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  3. Pooled it
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  17. Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors.International journal of environmental research and public health · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Peter J GoadsbyNIHR-Wellcome Trust King's Clinical Research Facility, Kings College, London, UK peter.goadsby@kcl.ac.uk.ORCID 0000-0003-3260-5904
David W DodickMayo Clinic Scottsdale, Scottsdale, Arizona, USA.
James M MartinezEli Lilly and Company, Indianapolis, Indiana, USA.
Margaret B FergusonEli Lilly and Company, Indianapolis, Indiana, USA.
Tina M OakesEli Lilly and Company, Indianapolis, Indiana, USA.
Qi ZhangSanofi, Bridgewater, New Jersey, USA.
Vladimir SkljarevskiEli Lilly and Company, Indianapolis, Indiana, USA.
Sheena K AuroraEli Lilly and Company, Indianapolis, Indiana, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveAs new migraine prevention treatments are developed, the onset of a preventive effect, how long it is maintained and whether patients initially non-responsive develop clinically meaningful responses with continued treatment can be assessed.

methodsAnalyses were conducted post-hoc of a double-blind, placebo-controlled, phase II-a study in patients with episodic migraine receiving galcanezumab 150 mg or placebo biweekly for 12 weeks (

resultsPatients were randomised to galcanezumab (n=107) or placebo (n=110). A significant (p=0.018) change of -0.89±0.11 (galcanezumab) vs -0.53±0.11 (placebo) migraine headache days indicated onset at week 1. Forty-seven per cent of galcanezumab and 25% of placebo patients responding at month 1 maintained response through months 2 and 3. Of non-responders at month 1, 27% on galcanezumab and 20% on placebo responded on months 2 and 3, and 50% of galcanezumab non-responders in months 1 and 2 responded on month 3, vs 24% on placebo.

conclusionsThe onset of efficacy of galcanezumab is within 1 week in a majority of patients, and patients receiving galcanezumab are twice more likely to maintain responses than placebo patients. Early non-responders may respond by month 2 or month 3. TRIAL REGISTRATION NUMBER: NCT01625988.

Indexed as

AdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMigraine DisordersTime FactorsTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistsgalcanezumabcalcitonin gene-related peptideCGRPclinical trialgalcanezumabLY2951742migraine

Identifiers

PMID31004075
PMCPMC6691875

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.