Evidence map›Paper›PMID 32930994›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2021

Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN).

Janet Ford, Cristina Tassorelli, Elizabeth Leroux, Shufang Wang, David Ayer, Russell Nichols, Holland Detke

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02614261 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 13% 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.

NCT02614261 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2021Enrolled1,117ConditionsChronic MigraineArmsGalcanezumab, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 23 citations in OpenAlex.

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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

7 authors at 3 institutions in 3 countries.

Janet FordLilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA. ford_janet@lilly.com.
Cristina TassorelliIRCCS C. Mondino Foundation, Pavia, Italy.
Elizabeth LerouxDepartment of Clinical Neuroscience, University of Calgary, Calgary, Canada.
Shufang WangLilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
David AyerLilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Russell NicholsLilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Holland DetkeLilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Eli Lilly (United States) · USUniversity of Calgary · CAUniversity of Pavia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate secondary outcomes including changes in functioning and disability associated with galcanezumab, a humanized monoclonal antibody to calcitonin gene-related peptide, in patients with chronic migraine.

methodsPatients randomly received galcanezumab (120 mg n = 278, 240 mg n = 277) or placebo (n = 558) during 3 months of double-blind treatment, followed by a 9-month open-label extension. The Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQv2.1) measured the impact of migraine on patient functioning. The Migraine Disability Assessment (MIDAS) quantified headache-related disability. Changes from baseline were analyzed with mixed model repeated measures or analysis of covariance.

resultsTotal MSQ score at baseline was 44.88 ± 18.02 (mean ± SD), indicating significant functional impairment. At Month 3, least squares (LS) mean change ± SE in total MSQ for galcanezumab-treated patients were 20.51 ± 1.49 (120 mg) and 20.49 ± 1.49 (240 mg), both statistically significantly greater vs placebo-treated patients (14.55 ± 1.21; both P < 0.001). Total MIDAS score at baseline was 67.24 ± 57.31 (mean ± SD). At Month 3, LS mean change ± SE from baseline in total MIDAS for galcanezumab-treated patients was statistically significantly greater than placebo for 120 mg group (placebo: - 11.53 ± 3.38 vs 120 mg: - 20.27 ± 4.07; P < 0.05) but not for 240 mg group (- 17.02 ± 4.05). At Month 12, within-group mean changes from baseline for total MSQ (28.56 ± 1.19 previous placebo; 29.53 ± 1.51 previous 120 mg; 25.83 ± 1.49 previous 240 mg) and MIDAS scores (- 28.47 ± 2.95 previous placebo; - 31.47 ± 3.69 previous 120 mg; - 31.13 ± 3.62 previous 240 mg) were statistically significant (P < 0.001) for the open-label treatment population regardless of previous double-blind treatment assignment.

conclusionsGalcanezumab-treated patients with chronic migraine reported statistically significant improvements in functioning and disability, representing a clinically significant change.

trial registrationClinicalTrials.gov registry: NCT02614261. Registered 25 November 2015.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersQuality of LifeSurveys and QuestionnairesTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedgalcanezumabCalcitonin gene-related peptideChronic migraineDisabilityGalcanezumabPatient-reported outcomesQuality of life

Identifiers

PMID32930994
PMCPMC7847867
OpenAlexW3085896652

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.