Evidence map›Paper›PMID 34153117›Full record

Trial reportHeadache2021

Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double-blind, placebo-controlled study.

Takao Takeshima, Fumihiko Sakai, Koichi Hirata, Noboru Imai, Yasuhiko Matsumori, Ryuji Yoshida, Cheng Peng, Sunfa Cheng, Daniel D Mikol

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03812224 (A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention), which is not on this map. Cited by 43 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 8 pooled it
–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.

NCT03812224 phase3completednot on this map

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

TypeinterventionalSponsorAmgenRan2019 to 2020Enrolled261ConditionsMigraineArmsErenumab, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
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  8. Guideline
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  15. Drugs for Migraine Prophylaxis.Deutsches Arzteblatt international · 2026
    Review
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  20. Observational
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.

Takao TakeshimaHeadache Center, Department of Neurology, Tominaga Hospital, Osaka, Japan.
Fumihiko SakaiDepartment of Neurology, Saitama International Headache Center, Saitama, Japan.
Koichi HirataHeadache Center, Dokkyo Medical University, Tochigi, Japan.
Noboru ImaiDepartment of Neurology, Japanese Red Cross Shizuoka Hospital, Shizuoka, Japan.
Yasuhiko MatsumoriSendai Headache and Neurology Clinic, Sendai, Japan.
Ryuji YoshidaResearch & Development, Amgen K.K., Tokyo, Japan.
Cheng PengGlobal Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.
Sunfa ChengGlobal Development, Amgen Inc., Thousand Oaks, CA, USA.
Daniel D MikolGlobal Development, Amgen Inc., Thousand Oaks, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesErenumab is a human anti-calcitonin gene-related peptide receptor monoclonal antibody approved for migraine prevention. Global studies have demonstrated its efficacy in chronic and episodic migraine (EM). Here we report the outcomes from a Phase 3 study of erenumab in Japanese patients with chronic migraine (CM) or EM.

methodsJapanese patients with EM (<15 headache days/month, including ≥4 migraine days/month) or CM (≥15 headache days/month, including ≥8 migraine days/month) were randomized 1:1 to placebo or erenumab 70 mg once monthly for a 24-week double-blind treatment phase (DBTP). The primary endpoint of change from baseline in mean monthly migraine days (MMD) over months 4, 5, and 6 of the DBTP was compared between erenumab and placebo groups. Secondary efficacy and safety endpoints were also assessed.

resultsA total of 261 patients were randomized to placebo (n = 131) or erenumab 70 mg (n = 130); all patients were included in the efficacy and safety analyses. The mean (standard deviation) MMD at baseline was 11.84 (5.70) for the placebo group and 12.40 (5.99) for erenumab 70 mg. The mean (standard error) change in MMD was -1.98 (0.38) for the placebo group (n = 131) and -3.60 (0.38) for erenumab 70 mg (n = 130). The difference in MMD reduction between groups was -1.67 (95% CI: -2.56, -0.78, p < 0.001) for EM and -1.57 (95% CI: -3.39, 0.24, p = 0.089) for CM. Adverse events (AEs) were consistent with earlier studies. The most frequent AEs (placebo, erenumab) were nasopharyngitis (28.2% and 26.9%, respectively), back pain (4.6% and 5.4%), and constipation (0.8% and 4.6%).

conclusionTreatment with erenumab 70 mg once monthly demonstrated favorable efficacy and safety findings in Japanese patients with EM or CM.

Indexed as

AdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodFemaleHumansJapanMaleMiddle AgedMigraine DisordersTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistserenumabchronic migraineepisodic migraineerenumabJapan

Identifiers

PMID34153117
PMCPMC8361926

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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.