Evidence map›Paper›PMID 32636324›Full record

Trial reportNeurology2020

One-year sustained efficacy of erenumab in episodic migraine: Results of the STRIVE study.

Peter J Goadsby, Uwe Reuter, Yngve Hallström, Gregor Broessner, Jo H Bonner, Feng Zhang, Ian K Wright, Denise E Chou, Jan Klatt, Hernan Picard and 2 more

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

Trial report in Neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02456740 (A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
7.1field-weighted citation impact, top 2% 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.

NCT02456740 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

TypeinterventionalSponsorAmgenRan2015 to 2017Enrolled955ConditionsMigraineArmsErenumab, Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Review
  9. Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Observational
  10. Article
  11. Article
  12. The ultimate guide to the anti-CGRP monoclonal antibodies galaxy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Review
  13. Article
  14. Migraine management: an update for the 2020s.Internal medicine journal · 2022
    Article
  15. Observational
  16. Review
  17. Efficacy and safety of erenumab in migraine prevention: evidences from direct and indirect comparisons.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Article
  18. Article
  19. Review
  20. Article
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

12 authors at 1 institution in 5 countries.

Peter J GoadsbyFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland. peter.goadsby@kcl.ac.uk.ORCID 0000-0003-3260-5904
Uwe ReuterFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Yngve HallströmFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Gregor BroessnerFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Jo H BonnerFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Feng ZhangFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Ian K WrightFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Denise E ChouFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Jan KlattFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Hernan PicardFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Robert A LenzFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Daniel D MikolFrom the NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College Hospital, London, UK; Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany; Neuro Center (Y.H.), St Görans Hospital, Stockholm, Sweden; Department of Neurology (G.B.), Headache Outpatient Clinic, Medical University of Innsbruck, Austria; Mercy Research (J.H.B.), St. Louis, MO; Amgen Inc. (F.Z., D.E.C., H.P., R.A.L., D.D.M.), Thousand Oaks, CA; Novartis Product Irl Ltd. (I.K.W.), Dublin, Ireland; and Novartis Pharma AG (J.K.), Basel, Switzerland.
Novartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine.

methodsPatients were randomized (n = 955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo or erenumab 70 or 140 mg. At week 24, 845 patients were rerandomized (1:1) to erenumab 70 or 140 mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75%, and 100% reduction in MMD, and safety/tolerability were assessed.

resultsMean MMD at DBTP baseline was 8.3. At week 52, mean changes (SE) from pre-DBTP baseline/week 24 (pre-ATP baseline) in MMD were -4.2 (0.2)/-1.1 (0.2) (70 mg) and -4.6 (0.2)/-1.8 (0.2) (140 mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70 mg (ATP), change in MMD from week 24 to 52 was -0.1 (0.3), and for those increasing from 70 (DBTP) to 140 mg (ATP), -1.8 (0.3). At week 52, 61.0%, 38.5%, and 19.8% of patients on erenumab 70 mg, and 64.9%, 40.8%, and 21.2% on erenumab 140 mg, achieved ≥50%, ≥75%, and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in ATP was similar to DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose.

conclusionOver 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding. CLINICALTRIALSGOV IDENTIFIER: NCT02456740. CLASSIFICATION OF EVIDENCE: Class II evidence that 52 weeks of treatment with erenumab 70 and 140 mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.

Indexed as

AdultAgedAnalgesicsAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersTreatment OutcomeAnalgesicsAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistserenumab

Identifiers

PMID32636324
PMCPMC7455346
OpenAlexW3041421066

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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.