Evidence map›Paper›PMID 31612482›Full record

Trial reportHeadache2019

A Randomized Phase 2 Study of Erenumab for the Prevention of Episodic Migraine in Japanese Adults.

Fumihiko Sakai, Takao Takeshima, Yoshihisa Tatsuoka, Koichi Hirata, Robert Lenz, Yi Wang, Sunfa Cheng, Toshiyasu Hirama, Daniel D Mikol

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

Trial report in Headache, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02630459 (A Phase 2, 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 40 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 9 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.

NCT02630459 phase2completednot on this map

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

TypeinterventionalSponsorAmgenRan2016 to 2019Enrolled475ConditionsMigraineArmsPlacebo, Erenumab
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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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.

Fumihiko SakaiSaitama International Headache Center, Saitama, Japan.
Takao TakeshimaHeadache Center, Department of Neurology, Tominaga Hospital, Osaka, Japan.
Yoshihisa TatsuokaDepartment of Neurology, Tatsuoka Neurology Clinic, Kyoto, Japan.
Koichi HirataDepartment of Neurology, Dokkyo Medical University, Tochigi, Japan.
Robert LenzGlobal Development, Amgen Inc., Thousand Oaks, CA, USA.
Yi WangGlobal Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.
Sunfa ChengGlobal Development, Amgen Inc., Thousand Oaks, CA, USA.
Toshiyasu HiramaResearch & Development, Amgen Astellas BioPharma K.K., Tokyo, Japan.
Daniel D MikolGlobal Development, Amgen Inc., Thousand Oaks, CA, USA.

Funding

Amgen Astellas BioPharma K.K.Amgen Inc
6 · The paper itself

Abstract

objectiveA phase 2, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab for the prevention of episodic migraine in Japanese patients was conducted.

backgroundPrevious global clinical studies have demonstrated the efficacy of erenumab in the prevention of migraine.

methodsPatients were randomized to placebo or erenumab 28, 70, or 140 mg administered subcutaneously once per month for 6 months. The primary endpoint was change from baseline in mean monthly migraine days over months 4-6 of the double-blind treatment phase. Secondary endpoints included the proportion of patients achieving ≥50% reduction from baseline in mean monthly migraine days (≥50% response) and change from baseline in mean monthly acute migraine-specific medication treatment days (MSMD) and mean Headache Impact Test (HIT-6™) scores. Efficacy outcomes were also determined at months 1, 2, and 3.

resultsFour hundred and seventy five patients were randomized 2:1:2:2 to placebo and erenumab 28, 70, and 140 mg, respectively. Greater reductions in monthly migraine days were observed for erenumab vs placebo with differences of -1.25 (95% CI: -2.10 to -0.41; P = .004), -2.31 (95% CI: -3.00 to -1.62; P < .001), and -1.89 (95% CI: -2.58 to -1.20; P < .001) days for erenumab 28, 70, and 140 mg. The odds of having a ≥50% response were 3.2, 5.6, and 4.7 times greater for erenumab 28 mg (95% CI: 1.30-7.88; P = .009), 70 mg (95% CI: 2.60-12.06; P < .001), and 140 mg (95% CI: 2.24-9.99; P < .001) than for placebo. Greater reductions from baseline in mean acute monthly MSMD were observed for erenumab vs placebo with differences of -1.07 (95% CI: -1.80 to -0.35; P = .004), -2.07 (95% CI: -2.66 to -1.49; P < .001), and -2.04 (95% CI: -2.63 to -1.45; P < .001) days for erenumab 28, 70, and 140 mg. Erenumab 70 and 140 mg also resulted in greater improvements in HIT-6™ scores. The safety profile was similar across treatment groups. The most common adverse event was nasopharyngitis, which occurred in 29.4% of patients in the placebo group and 28.9%-33.3% of patients in the erenumab groups.

conclusionMonthly subcutaneous injections of erenumab 70 mg demonstrated statistically significant and numerically maximal efficacy with a favorable safety profile, suggesting that erenumab is a potential new therapy for migraine prevention in Japan.

Indexed as

AdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodFemaleHumansJapanMaleMiddle AgedMigraine DisordersTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistserenumabepisodic migraineerenumabheadachemigraine preventionphase 2 trial

Identifiers

PMID31612482
PMCPMC6900095

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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.