Evidence map›Paper›PMID 40838472›Full record

Trial reportEuropean journal of neurology2025

Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache: Final Results From a Phase 4 Randomized Placebo-Controlled Study.

Stewart J Tepper, David W Dodick, Michel Lanteri-Minet, David Dolezil, Raquel Gil-Gouveia, Christian Lucas, Karolina Piasecka-Stryczynska, Gyöngyi Szabó, Daniel D Mikol, Mahan Chehrenama and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IVMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03971071 (A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT03971071 phase4completednot on this map

A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache

TypeinterventionalSponsorAmgenRan2019 to 2023Enrolled620ConditionsMigraine HeadacheArmsErenumab 70 mg, Erenumab 140 mg, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
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

13 authors.

Stewart J TepperThe New England Institute for Neurology and Headache, Stamford, Connecticut, USA.
David W DodickDepartment of Neurology, Mayo Clinic, Scottsdale, Arizona, USA.
Michel Lanteri-MinetPain Department and FHU InovPain, Centre Hospitalier Universitaire de Nice-Côte Azur and University, Nice, France.
David DolezilPrague Headache Center, DADO MEDICAL Sro, Prague, Czech Republic.
Raquel Gil-GouveiaNeurology Department, Hospital da luz luz Saude, Lisboa, Portugal.
Christian LucasDepartment of Pain CHU, Lille, France.
Karolina Piasecka-StryczynskaDepartment of Neurology, Poznań University of Medical Sciences, Poznań, Poland.
Gyöngyi SzabóÓbudai Egészségügyi Centrum, Budapest, Hungary.
Daniel D MikolAmgen Inc., Thousand Oaks, California, USA.
Mahan ChehrenamaAmgen Inc., Thousand Oaks, California, USA.
Denise E ChouAmgen Inc., Thousand Oaks, California, USA.
Zilu LiuAmgen Inc., Thousand Oaks, California, USA.
Gabriel Paiva da Silva LimaAmgen Inc., Thousand Oaks, California, USA.

Funding

Amgen Inc.
6 · The paper itself

Abstract

backgroundErenumab-induced medication overuse headache (MOH) remission in participants with chronic migraine (CM) in a prospective, Phase 4, randomized, placebo-controlled trial with an open-label treatment period (OLTP). We present 1-year results from the combined double-blind treatment period (DBTP) and OLTP for the stratified nonopioid cohort.

methodsParticipants with CM-MOH were randomized 1:1:1 to subcutaneous 70 or 140 mg erenumab every 4 weeks (QM) or placebo for the initial 24 weeks (DBTP). Those successfully completing DBTP could continue the 28-week OLTP, maintaining the same erenumab dose received during DBTP or, if receiving placebo, randomly assigned 1:1 to erenumab 70 or 140 mg QM. OLTP endpoints were exploratory.

resultsOverall, 552 participants received erenumab (70 mg, n = 274; 140 mg, n = 278); 95.3% completed OLTP. One-year MOH relapse in participants who achieved MOH remission at DBTP Month 6 was 2.7% (3/111) and 2.4% (3/124) with erenumab 70 and 140 mg, respectively; absence of MOH at study end was observed in 69.0% (189/274) and 75.5% (210/278) of participants. Sustained MOH absence over 1 year was reported in 60.5% (107/177) and 68.8% (119/173) of participants, respectively. Sustained improvements in measures of headache days, medication days, and function were observed in both groups. No new safety concerns were identified (grade ≥ 3, 35 [6.3%]; serious, 17 [3.1%]; adverse events leading to treatment discontinuation, 5 [0.9%]).

conclusionsErenumab was effective in inducing and sustaining MOH remission and improving function over 1 year. Treatment compliance remained high, with safety events consistent with erenumab's known safety profile.

trial registrationNCT03971071.

Indexed as

Antibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsHeadache Disorders, SecondaryAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistserenumabcalcitonin gene‐related peptideclinical trialerenumabheadache disordersmigraine disorderssecondary

Identifiers

PMID40838472
PMCPMC12368597

What OpenQuestion holds

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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.