Evidence map›Paper›PMID 35896988›Full record

Trial reportThe journal of headache and pain2022

Galcanezumab in episodic migraine: the phase 3, randomized, double-blind, placebo-controlled PERSIST study.

Bo Hu, Gang Li, Xiaohong Li, Shan Wu, Tingmin Yu, Xiang Li, Hongru Zhao, Zhihua Jia, Junpeng Zhuang, Shengyuan Yu

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 trial NCT03963232 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study), which is not on this map. Cited by 15 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 5 pooled it
5.1field-weighted citation impact, top 3% 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.

NCT03963232 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study

TypeinterventionalSponsorEli Lilly and CompanyRan2019 to 2022Enrolled520ConditionsEpisodic MigraineArmsGalcanezumab, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 5 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
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  5. Pooled it
  6. Trial
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  8. Drugs for Migraine Prophylaxis.Deutsches Arzteblatt international · 2026
    Review
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  10. Observational
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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

10 authors at 9 institutions in 1 country.

Bo Hu *Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Gang Li *Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Xiaohong LiDepartment of Neurology, Jinan Central Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.
Shan WuDepartment of Neurology, Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China.
Tingmin YuDepartment of Neurology, The Second Hospital of Jilin University, Changchun, Jilin, China.
Xiang LiDepartment of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Hongru ZhaoDepartment of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Zhihua JiaDepartment of Neurology, Chinese PLA General Hospital, Beijing, China.
Junpeng ZhuangEli Lilly and Company, Shanghai, China.
Shengyuan YuDepartment of Neurology, Chinese PLA General Hospital, Beijing, China. yusy1963@126.com.
Chinese PLA General Hospital · CNAffiliated Hospital of Guizhou Medical University · CNFudan University · CNHuashan Hospital · CNLilly (China) · CNSecond Affiliated Hospital of Jilin University · CNShanghai East Hospital · CNSoochow University · CNUnion Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGalcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated efficacy and good tolerability in patients with episodic migraine in previous phase 3 trials. We report results from the PERSIST study, which was designed to assess the efficacy and safety of galcanezumab in patients with episodic migraine from China, India, and Russia.

methodsThis phase 3 study was conducted at 40 centers in China (n = 26), India (n = 10), and Russia (n = 4). Eligible adult patients with episodic migraine were randomized in a 1:1 ratio to receive monthly galcanezumab 120 mg (with 240 mg loading dose) or placebo during a double-blind, 3-month treatment period. The primary endpoint was the overall mean change from baseline in monthly migraine headache days (MHDs). Key secondary endpoints were the mean proportion of patients with ≥ 50%, ≥ 75%, and 100% reductions from baseline in MHDs and mean change in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role Function-Restrictive domain score.

resultsIn total, 520 patients were randomized and received at least one dose of galcanezumab (N = 261) or placebo (N = 259). The least squares (LS) mean reduction from baseline in monthly MHDs over 3 months was significantly greater with galcanezumab compared with placebo (-3.81 days vs. -1.99 days; p < 0.0001). Significantly greater mean proportions of patients with galcanezumab versus placebo had ≥ 50%, ≥ 75%, and 100% reductions from baseline in MHDs (all p < 0.0001). The overall mean improvement from baseline in MSQ Role Function-Restrictive score over 3 months was significantly greater with galcanezumab versus placebo (p < 0.0001). There were no clinically meaningful differences between the galcanezumab and placebo group on any safety parameters except for a higher incidence of injection site pruritus (5.0% vs. 0.0%), injection site reaction (3.8% vs. 0.4%), and injection site discomfort (2.3% vs. 0.0%). TEAEs related to injection sites were mild in severity, except in 1 patient who had a moderate injection site reaction. Six serious adverse events were reported by 6 patients (2 galcanezumab, 4 placebo).

conclusionsGalcanezumab 120 mg once monthly was effective and well tolerated in patients with episodic migraine from China, India, and Russia.

trial registrationClinicalTrials.gov Identifier NCT03963232 (PERSIST), registered May 24, 2019.

Indexed as

Migraine DisordersQuality of LifeAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansInjection Site ReactionTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedgalcanezumabCalcitonin gene-related peptideEpisodic migraineGalcanezumabHumanized monoclonal antibody

Identifiers

PMID35896988
PMCPMC9330971
OpenAlexW4288060270

What OpenQuestion holds

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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.