Evidence map›Paper›PMID 34542830›Full record

Trial reportAdvances in therapy2021

Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial.

Uwe Reuter, Christian Lucas, David Dolezil, Austin L Hand, Martha D Port, Russell M Nichols, Chad Stroud, Antje Tockhorn-Heidenreich, Holland C Detke

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

Trial report in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03559257 (A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 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.

NCT03559257 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2019Enrolled463ConditionsMigraineArmsGalcanezumab, Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

9 authors.

Uwe ReuterCharité Universitätsmedizin Berlin, Berlin, Germany.
Christian LucasHôpital Salengro, CHU de Lille, Lille, France.
David DolezilDADO MEDICAL, Prague, Czech Republic.
Austin L HandIQVIA, Durham, NC, 27703, USA.
Martha D PortEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Russell M NicholsEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Chad StroudEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Antje Tockhorn-HeidenreichEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Holland C DetkeEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. detke_holland_c@lilly.com.ORCID http://orcid.org/0000-0002-1316-6064

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionResults from the open-label extension of the phase 3b CONQUER trial are presented to evaluate the effectiveness and safety of galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, for up to 6 months in patients with multiple prior migraine preventive treatment failures.

methodsPatients were 18-75 years old with episodic or chronic migraine and 2-4 standard-of-care migraine preventive medication category failures. After 3 months of randomized treatment with galcanezumab (120 mg/month with 240 mg loading dose; n = 232) or placebo (n = 230), patients entered a 3-month open-label extension (120 mg/month galcanezumab with a blinded 240 mg loading dose for previous-placebo patients). Primary efficacy measure was mean change from double-blind baseline in monthly migraine headache days.

resultsA total of 432/449 patients (96%) who entered open-label treatment completed the study. Mean change in monthly migraine headache days in the total population, which was - 1.3 for placebo and - 4.4 for galcanezumab patients at the end of double-blind treatment (p < 0.001), was - 5.2 and - 5.6, respectively, at the end of open-label treatment with galcanezumab. Among patients with episodic migraine, mean change in monthly migraine headache days had been - 0.6 for placebo and - 2.8 for galcanezumab after double-blind treatment (p < 0.001) and was - 4.5 and - 3.8, respectively, after open-label treatment. Among patients with chronic migraine, mean change in monthly migraine headache days had been - 2.5 for placebo and - 6.6 for galcanezumab after double-blind treatment (p < 0.001) and was - 6.5 and - 8.2, respectively, after open-label treatment. Adverse events were similar to those observed during double-blind placebo treatment. Review of data in elderly patients (65-75 years of age) indicated that galcanezumab was well tolerated in this age group, with no safety issues identified.

conclusionsGalcanezumab was effective and safe during open-label treatment in patients who had experienced failures of previous migraine preventives. CLINICAL

trial registrationClinicalTrials.gov identifier NCT03559257.

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersAdolescentAdultAgedAntibodies, MonoclonalHumansMiddle AgedTreatment OutcomeYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedgalcanezumabCGRPChronic migraineElderlyEpisodic migraineGalcanezumabMigraine preventiveMonoclonal antibodyTreatment failure

Identifiers

PMID34542830
PMCPMC8523004

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.