Evidence map›Paper›PMID 35041159›Full record

Trial reportClinical drug investigation2022

Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER).

Stewart J Tepper, Jessica Ailani, Janet H Ford, Russell M Nichols, Lily Q Li, Phebe Kemmer, Austin L Hand, Antje Tockhorn-Heidenreich

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 23% of its field
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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Multimodal digital health treatments for Chronic Migraine associated with Medication Overuse Headache: a literature appraisal and results of a single-arm open trial (the BE-HOME program).Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  4. Article
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 2 countries.

Stewart J TepperDepartment of Neurology, Geisel School of Medicine at Dartmouth, 1 Rope Ferry Rd, Hanover, NH, 03755, USA.
Jessica AilaniDepartment of Neurology, Medstar Georgetown University, 3800 Reservoir Rd NW, Washington, DC, 20007, USA.
Janet H FordHealth Outcomes and Real-World Evidence, Biomedicines, Eli Lilly and Company, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN, 46285, USA. ford_janet@lilly.com.ORCID http://orcid.org/0000-0001-7966-7737
Russell M NicholsClinical, Eli Lilly and Company, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN, 46285, USA.
Lily Q LiClinical, Eli Lilly and Company, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN, 46285, USA.
Phebe KemmerDepartment of Statistics-Neuroscience/Urology, Eli Lilly and Company, Lilly Corporate Center, 893 Delaware St, Indianapolis, IN, 46285, USA.
Austin L HandDepartments of Statistics, IQVIA, 4820 Emperor Blvd, Durham, NC, 27703, USA.
Antje Tockhorn-HeidenreichGPORWE International, Eli Lilly and Company, Bracknell, RG12 1PU, UK.
Eli Lilly (United States) · USDartmouth College · USEli Lilly (United Kingdom) · GBGeorgetown University · USIQVIA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesPatients with migraine and prior preventive treatment failures have a significant burden on quality of life and disability. The CONQUER study evaluated the effects of galcanezumab on patient functioning, disability, and health status in episodic or chronic migraine with a previous failure of two to four migraine preventive medication categories.

methodsPatients with two to four preventive migraine treatment category failures received galcanezumab 120 mg/month (240-mg loading dose) or placebo subcutaneously, for 3 months (double-blind period). In the 3-month open-label period, all patients received galcanezumab irrespective of the treatment received in the double-blind period. Changes in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ), Migraine Disability Assessment (MIDAS), and European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) scores were assessed.

resultsA total of 462 patients were randomized to receive galcanezumab (N = 232) or placebo (N = 230). At month 3, improvement in the MSQ Role-Function-Restrictive score from baseline was significantly greater for galcanezumab (23.19 ± 1.34) vs placebo (10.66 ± 1.33) [p ≤ 0.0001]. Significant improvements in remaining MSQ domains and total MSQ scores were observed (p < 0.0001) during the double-blind period. MIDAS total scores were significantly (p ≤ 0.0001) reduced with galcanezumab (- 21.10 + 3.32) vs placebo (- 3.30 + 3.28). EQ-5D-5L visual analog scale scores improved for galcanezumab (3.40 + 1.31) vs placebo (- 0.09 + 1.29; p = 0.028). During the open-label period, quality of life continued to improve for galcanezumab, with patients previously assigned to placebo reaching similar results. During both study periods, similar findings were reported in subpopulations with episodic migraine and chronic migraine.

conclusionsGalcanezumab significantly improved functioning and reduced disability in patients with episodic migraine and chronic migraine and two to four migraine preventive treatment category failures. CLINICAL

trial registrationNCT03559257, registration date: 6 June, 2018.

Indexed as

Migraine DisordersQuality of LifeAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansTreatment OutcomeAntibodies, Monoclonal, Humanizedgalcanezumab

Identifiers

PMID35041159
PMCPMC8930939
OpenAlexW4206535798

What OpenQuestion holds

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LicenceCC BY-NC
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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.