Evidence map›Paper›PMID 30996056›Full record

Trial reportNeurology2019

Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial.

Stewart J Tepper, Hans-Christoph Diener, Messoud Ashina, Jan Lewis Brandes, Deborah I Friedman, Uwe Reuter, Sunfa Cheng, Jon Nilsen, Dean K Leonardi, Robert A Lenz and 1 more

2 registry-linked trialsAbstract 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. It is linked to 2 registered trials, which are not on this map. Cited by 95 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 8 pooled it
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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.

NCT02066415 phase2completednot on this map

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention

TypeinterventionalSponsorAmgenRan2014 to 2016Enrolled667ConditionsTreatment for Prevention of Chronic MigraineArmsErenumab, Placebo
NCT04361721 unknown statusnot on this mapstarted 2020, after this paper: background citation

Neurophysiological, Biomolecular and Psychological Aspects of Erenumab Treatment in Chronic Migraine: an Open Label, Hypothesis Generator Study

TypeobservationalSponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2020 to 2021Enrolled40ConditionsChronic MigraineArmsErenumab
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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35 more citing papers are in PubMed but not listed here.

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

11 authors.

Stewart J TepperFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA. sjtepper@gmail.com.
Hans-Christoph DienerFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Messoud AshinaFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Jan Lewis BrandesFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Deborah I FriedmanFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Uwe ReuterFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Sunfa ChengFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Jon NilsenFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Dean K LeonardiFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Robert A LenzFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.
Daniel D MikolFrom the Geisel School of Medicine at Dartmouth (S.J.T.), Hanover, NH; Department of Neurology (H.-C.D.), University of Duisburg-Essen, Germany; Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology (J.L.B.), Vanderbilt University School of Medicine; Nashville Neuroscience Group (J.L.B.), TN; Neurology and Neurotherapeutics and Ophthalmology (D.I.F.), University of Texas Southwestern Medical Center, Dallas; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; and Amgen Inc (S.C., J.N., D.K.L., R.A.L., D.D.M.), Thousand Oaks, CA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the effect of erenumab, a human anti-calcitonin gene-related peptide receptor monoclonal antibody, in patients with chronic migraine and medication overuse.

methodsIn this double-blind, placebo-controlled study, 667 adults with chronic migraine were randomized (3:2:2) to placebo or erenumab (70 or 140 mg), stratified by region and medication overuse status. Data from patients with baseline medication overuse at baseline were used to assess changes in monthly migraine days, acute migraine-specific medication treatment days, and proportion of patients achieving ≥50% reduction from baseline in monthly migraine days.

resultsOf 667 patients randomized, 41% (n = 274) met medication overuse criteria. In the medication overuse subgroup, erenumab 70 or 140 mg groups had greater reductions than the placebo group at month 3 in monthly migraine days (mean [95% confidence interval] -6.6 [-8.0 to -5.3] and -6.6 [-8.0 to -5.3] vs -3.5 [-4.6 to -2.4]) and acute migraine-specific medication treatment days (-5.4 [-6.5 to -4.4] and -4.9 [-6.0 to -3.8] vs -2.1 [-3.0 to -1.2]). In the placebo and 70 and 140 mg groups, ≥50% reductions in monthly migraine days were achieved by 18%, 36% (odds ratio [95% confidence interval] 2.67 [1.36-5.22]) and 35% (odds ratio 2.51 [1.28-4.94]). These clinical responses paralleled improvements in patient-reported outcomes with a consistent benefit of erenumab across multiple measures of impact, disability, and health-related quality of life. The observed treatment effects were similar in the non-medication overuse subgroup.

conclusionsErenumab reduced migraine frequency and acute migraine-specific medication treatment days in patients with chronic migraine and medication overuse, improving disability and quality of life. CLINICALTRIALSGOV IDENTIFIER: NCT02066415. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that erenumab reduces monthly migraine days at 3 months in patients with chronic migraine and medication overuse.

Indexed as

Prescription Drug OveruseAdultAnalgesicsAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsChronic DiseaseFemaleHumansMaleMiddle AgedMigraine DisordersTryptaminesAnalgesicsAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistserenumabTryptamines

Identifiers

PMID30996056
PMCPMC6598821

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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.