Evidence map›Paper›PMID 34743579›Full record

Trial reportCephalalgia : an international journal of headache2022

Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial.

Uwe Reuter, Marc Ehrlich, Astrid Gendolla, Axel Heinze, Jan Klatt, Shihua Wen, Peggy Hours-Zesiger, Jacqueline Nickisch, Christian Sieder, Christian Hentschke and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in Cephalalgia : an international journal of headache, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03828539 (Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting), which is not on this map. Cited by 75 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 6 pooled it
19.2field-weighted citation impact, top 1% 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.

NCT03828539 phase4completednot on this map

Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting

TypeinterventionalSponsorNovartis PharmaceuticalsRan2019 to 2020Enrolled777ConditionsMigraineArmsErenumab, Topiramate, Erenumab matching placebo, Topiramate matching placebo
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 6 syntheses or guidelines pooled it, 165 citations in OpenAlex.

  1. Efficacy and safety of CGRP monoclonal antibodies in chronic migraine: a systematic review integrating randomized and real-world evidence.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
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  20. Drugs for Migraine Prophylaxis.Deutsches Arzteblatt international · 2026
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15 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 at 5 institutions in 3 countries.

Uwe ReuterDepartment of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-8527-0725
Marc EhrlichNovartis Pharma GmbH, Nuremberg, Germany.
Astrid GendollaPraxis Gendolla, Essen, Germany.
Axel HeinzeThe Kiel Migraine and Headache Centre, Kiel, Germany.
Jan KlattNovartis Pharma AG, Basel, Switzerland.
Shihua WenNovartis AG, New York, NY, USA.
Peggy Hours-ZesigerNovartis Pharma AG, Basel, Switzerland.
Jacqueline NickischNovartis Pharma GmbH, Nuremberg, Germany.
Christian SiederNovartis Pharma GmbH, Nuremberg, Germany.
Christian HentschkeNovartis Pharma GmbH, Nuremberg, Germany.
Monika Maier-PeuschelNovartis Pharma GmbH, Nuremberg, Germany.
Novartis (Germany) · DENovartis (Switzerland) · CHClinical Research Center Kiel · DENovartis (United States) · USUniversitätsmedizin Greifswald · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe compared the tolerability and efficacy of erenumab, a monoclonal antibody binding to the calcitonin gene-related peptide receptor, to topiramate for migraine prophylaxis in adults.

methodsHER-MES was a 24-week, randomised, double-blind, double-dummy, controlled trial conducted in 82 sites in Germany. Patients with ≥4 migraine days per month and naïve to study drugs were randomly assigned (1:1) to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo (erenumab group) or oral topiramate at the individual dose with optimal efficacy (50-100 mg/day) plus erenumab placebo (topiramate group).The primary endpoint was medication discontinuation due to an adverse event during the double-blind phase. The proportion of patients that achieved ≥50% reduction from baseline in monthly migraine days during the last 3 months of the double-blind phase was a secondary endpoint.

resultsSeven hundred and seventy-seven patients were randomised (from 22 February 2019 to 29 July, 2020) and 95.1% completed the study. In the erenumab group, 10.6% discontinued medication due to adverse events compared to 38.9% in the topiramate group (odds ratio, 0.19; 95% confidence interval 0.13-0.27;

conclusionsErenumab demonstrated a favourable tolerability and efficacy profile compared to topiramate.Trial registration: ClinicalTrials.gov NCT03828539, URL: https://clinicaltrials.gov/ct2/show/NCT03828539.

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansTopiramateTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistserenumabTopiramateCGRPErenumabhead-to-head studymigraineprophylaxistopiramate

Identifiers

PMID34743579
PMCPMC8793299
OpenAlexW3212380527

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.