Evidence map›Paper›PMID 35139816›Full record

Trial reportThe journal of headache and pain2022

Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients.

Takao Takeshima, Masami Nakai, Yoshiyuki Shibasaki, Miki Ishida, Byung-Kun Kim, Xiaoping Ning, Nobuyuki Koga

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The journal of headache and pain, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT03303079 phase2 / phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine

TypeinterventionalSponsorOtsuka Pharmaceutical Co., Ltd.Ran2017 to 2019Enrolled571ConditionsMigraineArmsTEV-48125, TEV-48125 or placebo, Placebo
NCT03303092 phase2 / phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine

TypeinterventionalSponsorOtsuka Pharmaceutical Co., Ltd.Ran2017 to 2019Enrolled357ConditionsMigraineArmsTEV-48125, TEV-48125 or placebo, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors.International journal of environmental research and public health · 2022
    Article
  10. 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

7 authors at 4 institutions in 3 countries.

Takao TakeshimaHeadache Center, Department of Neurology, Tominaga Hospital, 1-4-48 Minatomachi Naniwa-ku, Osaka-shi, Osaka, 556-0017, Japan.
Masami NakaiMedical Affairs, Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, Osaka, 540-0021, Japan. Nakai.Masami@otsuka.jp.
Yoshiyuki ShibasakiMedical Affairs, Otsuka Pharmaceutical Co., Ltd., Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo, 108-8242, Japan.
Miki IshidaHeadquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, Osaka, 540-0021, Japan.
Byung-Kun KimNowon Eulji Medical Center, Eulji University School of Medicine, 68 Hangeulbiseok-ro, Nowon-gu, Seoul, 01830, Republic of Korea.
Xiaoping NingSpeciality Clinical Development, Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Pkwy, West Chester, PA, 19380, USA.
Nobuyuki KogaMedical Affairs, Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima, 771-0192, Japan.
Otsuka (Japan) · JPEulji University · KRTeva Pharmaceuticals (United States) · USTominaga hospital · JP

Funding

Otsuka Pharmaceutical Co., Ltd. NA
6 · The paper itself

Abstract

backgroundEarly onset of action has become recognized as an important efficacy feature of preventive migraine treatment, which can help overcome adherence issues commonly associated with older medications. Preventive treatments that target the calcitonin gene-related peptide (CGRP) or the CGRP receptor have been previously shown to provide early onset of action.

methodsThis subanalysis of primary endpoints of two separate phase 2b/3 studies sought to determine the onset of action of fremanezumab in Japanese and Korean patients with episodic migraine (EM) and chronic migraine (CM).

resultsIn EM patients (n = 357), both fremanezumab quarterly and fremanezumab monthly led to greater reductions in weekly migraine days (days/week) than placebo from the first week after the initial injection and thereafter during the remainder of the study period. Similarly, CM patients (n = 571) had a greater reduction in headache days of at least moderate severity (days/week) with fremanezumab (total) than placebo. The percentage of patients with a migraine day (EM) or headache day at least moderate severity (CM) was lower in those treated with fremanezumab than placebo and this effect was apparent from as early as Day 2 (1 day after first injection).

conclusionsThese results suggest that fremanezumab has an early onset of action, as noted in previous post hoc analyses of anti-CGRP monoclonal antibodies.

trial registrationClinicalTrials.gov. NCT03303092 , Registered 5 October 2017, NCT03303079 , Registered 5 October 2017.

Indexed as

Antibodies, MonoclonalMigraine DisordersDouble-Blind MethodHumansJapanRepublic of KoreaTreatment OutcomeAntibodies, MonoclonalfremanezumabCalcitonin gene-related peptideChronic migraineEarly onsetEpisodic migraineFremanezumabJapaneseKorean

Identifiers

PMID35139816
PMCPMC8903536
OpenAlexW4210836460

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.