Evidence map›Paper›PMID 35201674›Full record

Trial reportBrain and behavior2022

Early onset of efficacy with erenumab for migraine prevention in Japanese patients: Analysis of two randomized, double-blind, placebo-controlled studies.

Koichi Hirata, Takao Takeshima, Fumihiko Sakai, Noboru Imai, Yasuhiko Matsumori, Yoshihisa Tatsuoka, Yotaro Numachi, Ryuji Yoshida, Cheng Peng, Daniel D Mikol and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Brain and behavior, 2022. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 36% 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.

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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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 7 institutions in 2 countries.

Koichi HirataDepartment of Neurology, Dokkyo Medical University, Tochigi, Japan.
Takao TakeshimaDepartment of Neurology, Tominaga Hospital, Osaka, Japan.
Fumihiko SakaiSaitama International Headache Center, Saitama, Japan.
Noboru ImaiDepartment of Neurology, Japanese Red Cross Shizuoka Hospital, Shizuoka, Japan.
Yasuhiko MatsumoriSendai Headache and Neurology Clinic, Sendai, Japan.
Yoshihisa TatsuokaDepartment of Neurology, Tatsuoka Neurology Clinic, Kyoto, Japan.
Yotaro NumachiAmgen K.K., Research & Development, Tokyo, Japan.
Ryuji YoshidaAmgen K.K., Research & Development, Tokyo, Japan.
Cheng PengAmgen Inc., Global Biostatistical Science, Thousand Oaks, California, USA.
Daniel D MikolAmgen Inc., Global Development, Thousand Oaks, California, USA.
Gabriel Paiva da Silva LimaAmgen Inc., Global Development, Thousand Oaks, California, USA.
Sunfa ChengAmgen Inc., Global Development, Thousand Oaks, California, USA.
Amgen (United States) · USMSD K.K. (Japan) · JPDokkyo Medical University · JPOno Clinic · JPSaitama International Medical Center · JPShizuoka Red Cross Hospital · JPTominaga hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn two 24-week migraine prevention studies in Japan, erenumab was associated with significantly greater reductions in migraine frequency versus placebo over Weeks 13-24 (primary endpoint). This post hoc analysis evaluated the onset of efficacy within the first 4 weeks after the initiation of erenumab from the 24-week double-blind periods of these studies.

methodsPlacebo-adjusted differences in least squares mean (LSM) change from baseline in weekly migraine days (WMD) were assessed weekly in each study and by migraine type (episodic (EM]/chronic [CM]) (Study 20170609).

resultsA total of 407 patients from Study 20120309 (70 mg: N = 135; 140 mg: N = 136; placebo: N = 136) and 261 patients from Study 20170609 ([EM] 70 mg: N = 78; placebo: N = 81; [CM] 70 mg: N = 52; placebo: N = 50) were included. For Study 20120309, onset of efficacy was observed as early as Week 1 in favor of erenumab versus placebo. Placebo-adjusted differences in LSM (95% confidence interval [CI]) change from baseline in WMD at Week 1 were -0.38 (-0.71 to -0.05; p = .022) and -0.49 (-0.82 to -0.16; p = .004) in favor of erenumab 70 and 140 mg, respectively. For Study 20170609, significant placebo-adjusted differences were observed with erenumab 70 mg at Week 1 in patients with EM (LSM [95% CI]: -0.55 [-0.97 to -0.12; p = .012]), and at Week 2 in patients with CM (LSM [95% CI]: -0.81 [-1.53 to -0.09; p = .028]) and for the overall population (LSM [95% CI]: -0.71 [-1.09 to -0.33; p < .001]).

conclusionsErenumab treatment significantly reduced WMD compared with placebo. Onset of erenumab efficacy occurred as early as Week 1 in patients with migraine.

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansJapanTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistserenumabcalcitonin gene-related peptidechronic migraineepisodic migraineerenumabonset of efficacy

Identifiers

PMID35201674
PMCPMC8933787
OpenAlexW4214500833

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.