Evidence map›Paper›PMID 38581615›Full record

ArticleNeurology and therapy2024

Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study.

Takao Takeshima, Hikaru Doi, Satomi Ooba, Yuka Tanji, Akichika Ozeki, Mika Komori

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Neurology and therapy, 2024. 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 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 30% 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.

NCT02959177 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 (Galcanezumab) in Japanese Patients With Episodic Migraine

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2019Enrolled459ConditionsMigraineArmsGalcanezumab, Placebo
NCT02959190 phase3completednot on this map

A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 (Galcanezumab) in Japanese Patients With Migraine

TypeinterventionalSponsorEli Lilly and CompanyRan2017 to 2019Enrolled311ConditionsMigraineArmsGalcanezumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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

6 authors at 3 institutions in 1 country.

Takao TakeshimaHeadache Center, Department of Neurology, Tominaga Hospital, Osaka, Japan.ORCID http://orcid.org/0000-0003-2678-6956
Hikaru DoiDoi Clinic Internal Medicine/Neurology, Hiroshima, Japan.
Satomi OobaDepartment of Neurosurgery and Headache, Ooba Clinic, Oita, Japan.
Yuka TanjiJapan Drug Development and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogamidori, Chuo-ku, Kobe, 651-0086, Japan.ORCID http://orcid.org/0000-0001-7850-1946
Akichika OzekiJapan Drug Development and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogamidori, Chuo-ku, Kobe, 651-0086, Japan.ORCID http://orcid.org/0000-0001-5510-4219
Mika KomoriJapan Drug Development and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogamidori, Chuo-ku, Kobe, 651-0086, Japan. komori_mika@lilly.com.ORCID http://orcid.org/0000-0003-1887-1296
Eli Lilly (Japan) · JPOno Clinic · JPTominaga hospital · JP

Funding

Daiichi-Sankyo Funding for medical writing assistance onlyEli Lilly Japan funding for medical writing assistanceEli Lilly Japan funding for Rapid Service/Open Access feesEli Lilly Japan Study funding
6 · The paper itself

Abstract

introductionThis analysis of two Japanese clinical trials evaluated efficacy and safety after galcanezumab (GMB) discontinuation in patients with episodic migraine (EM) and chronic migraine (CM).

methodsData were from a 6-month, randomized, double-blind, placebo [PBO]-controlled primary trial (patients with EM) and a 12-month open-label extension trial (patients with EM/CM). Patients received 6 months' (primary) or 12/18 months' (extension) treatment with GMB 120 mg (GMB120) plus 240-mg loading dose or 240 mg (GMB240) with 4 months' post-treatment follow-up. Efficacy was assessed as number of monthly migraine headache days during post-treatment. Safety was assessed via post-treatment-emergent adverse events (PTEAEs).

resultsThe analysis population included 186 patients from the primary trial (PBO N = 93; GMB120 N = 45; GMB240 N = 48), 220 patients with EM from the extension trial (PBO/GMB120 N = 57; PBO/GMB240 N = 55; GMB120/GMB120 N = 55; GMB240/GMB240 N = 53), and 55 patients with CM (GMB120 N = 28; GMB240 N = 27). In patients with EM receiving 6 months' GMB120, mean standard deviation (SD) monthly migraine headache days increased from 5.69 (4.64) at treatment end to 6.24 (4.37) at end of follow-up but did not return to pre-treatment levels (8.80 [2.96]). In the extension trial, mean monthly migraine headache days in patients with EM receiving GMB120 were 4.13 (3.85) after 12 months and 4.45 (3.78) at end of follow-up, and 3.59 (3.48) after 18 months and 3.91 (3.57) at end of follow-up. Monthly migraine headache days in patients with CM (12 months' GMB120) were 10.71 (4.61) at treatment end and 11.17 (5.64) at end of follow-up (pre-treatment 20.15 [4.65]). Similar results were seen for patients receiving GMB240. The most observed PTEAE after GMB discontinuation was nasopharyngitis.

conclusionGalcanezumab exhibited post-treatment efficacy for up to 4 months in Japanese patients with EM and with CM. No unexpected safety signals were observed. CLINICAL

trial registrationClinicalTrials.gov, NCT02959177 and NCT02959190.

Indexed as

Anti-CGRP mAbClinical factorsDrug discontinuationGalcanezumabJapanMigraine disordersMigraine headache daysOpen-label extension studyPost-treatmentRandomized controlled trial

Identifiers

PMID38581615
PMCPMC11136910
OpenAlexW4394013126

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.