Evidence map›Paper›PMID 31270220›Full record

Trial reportNeurology2019

Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability.

Janet H Ford, David W Ayer, Qi Zhang, Jeffrey N Carter, Elizabeth Leroux, Vladimir Skljarevski, Sheena K Aurora, Antje Tockhorn-Heidenreich, Richard B Lipton

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
3.9field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 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

9 authors at 4 institutions in 2 countries.

Janet H FordFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY. ford_janet@lilly.com.
David W AyerFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
Qi ZhangFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
Jeffrey N CarterFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
Elizabeth LerouxFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
Vladimir SkljarevskiFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
Sheena K AuroraFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
Antje Tockhorn-HeidenreichFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
Richard B LiptonFrom Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.
University of Calgary · CAAlbert Einstein College of Medicine · USSanofi (United States) · USElanco (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate changes from baseline in patient-reported outcomes for measures of functioning and disability among patients with migraine treated with galcanezumab or placebo.

methodsPatients with episodic migraine (4-14 monthly migraine headache days) were treated with either galcanezumab (Evaluation of LY2951742 in the Prevention of Episodic Migraine [EVOLVE]-1: 120 mg n = 210, 240 mg n = 208; EVOLVE-2: 120 mg n = 226, 240 mg n = 220) or placebo (EVOLVE-1 n = 425; EVOLVE-2 n = 450) during 6 months of treatment. Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) measured the effect of migraine on patient functioning (physical and emotional) in 3 domains, and the Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events. Both were collected at baseline and during the treatment period (MSQv2.1 = monthly; MIDAS = months 3 and 6 only).

resultsDifferences in MSQv2.1 total score least squares (LS) mean change from baseline (month 4-6) for galcanezumab (120 and 240 mg, respectively) were superior to placebo (EVOLVE-1 = 7.3 and 6.7 [both

conclusionsPatients with episodic migraine treated with galcanezumab reported significant and clinically meaningful improvements in daily functioning and decreased disability compared with patients who received placebo. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with migraine, galcanezumab (120 mg or 240 mg) given once monthly improved functioning and reduced disability.

Indexed as

EfficiencyQuality of LifeSick LeaveSocial ParticipationAdultAntibodies, Monoclonal, HumanizedCost of IllnessFemaleHumansMaleMiddle AgedMigraine DisordersAntibodies, Monoclonal, Humanizedgalcanezumab

Identifiers

PMID31270220
PMCPMC6693431
OpenAlexW2955652411

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.