Evidence map›Paper›PMID 37542222›Full record

Trial reportThe journal of headache and pain2023

Galcanezumab in patients with episodic migraine: results from the open-label period of the phase 3 PERSIST study.

Jiying Zhou, Lianmei Zhong, Debashish Chowdhury, Kirill Skorobogatykh, Guogang Luo, Xiaosu Yang, Mingjie Zhang, Lingli Sun, Hui Liu, Chenxi Qian and 1 more

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, 2023. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
  3. A narrative review of autophagy in migraine.Frontiers in neuroscience · 2025
    Review
  4. Review
  5. Review
  6. 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

11 authors at 7 institutions in 2 countries.

Jiying ZhouDepartment of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Lianmei ZhongDepartment of Neurology, First Affiliated Hospital of Kunming Medical University, Kunming, China.
Debashish ChowdhuryGobind Ballabh Pant Institute of Post Graduate Medical Education and Research, New Delhi, India.
Kirill SkorobogatykhUniversity Headache Clinic, Moscow, Russia.
Guogang LuoStroke Centre and Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Xiaosu YangDepartment of Neurology, Xiangya Hospital, Central South University, Changsha, China.
Mingjie ZhangDepartment of Neurology, Chinese PLA General Hospital, Beijing, China.
Lingli SunEli Lilly and Company, Shanghai, China.
Hui LiuEli Lilly and Company, Shanghai, China.
Chenxi QianEli Lilly and Company, Shanghai, China.
Shengyuan YuDepartment of Neurology, Chinese PLA General Hospital, Beijing, China. yusy1963@126.com.
Lilly (China) · CNChinese PLA General Hospital · CNFirst Affiliated Hospital of Chongqing Medical University · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNInstitute of Post Graduate Medical Education and Research · INKunming Medical University · CNXiangya Hospital Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase 3 randomized PERSIST study demonstrated the efficacy and tolerability of galcanezumab, a humanized anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for prevention of episodic migraines. We present findings from the open-label extension (OLE) of PERSIST, which evaluated the long-term efficacy and safety of galcanezumab in patients from China, India, and Russia.

methodsPatients completing the 3-month double-blind period of PERSIST were eligible for the 3-month OLE. Patients previously randomized to galcanezumab (GMB/GMB group) continued to receive galcanezumab 120 mg at all three visits during the OLE whereas patients randomized to placebo received a 240 mg loading dose of galcanezumab and then two 120 mg doses (PBO/GMB group). The primary outcome was the mean change (from double-blind baseline) in the number of monthly migraine headache days (MHDs) to month 6. Other endpoints included percent reduction in monthly MHDs from double-blind baseline to month 6, functional outcomes, safety and tolerability.

resultsOverall, 99% of patients completing the double-blind period entered the OLE, and 96% completed through month 6. Patients in the GMB/GMB group achieved continued improvements in efficacy, with the reduction from baseline in the mean number of monthly MHDs, and slightly increasing from 4.01 days at the end of the double-blind period to 4.62 at the end of the OLE. Of patients who were ≥ 50% responders to galcanezumab at month 3, 66% maintained this response through to month 6. Patients in the PBO/GMB group experienced a rapid reduction in the number of monthly MHDs after initiation of galcanezumab, with a mean reduction from baseline of 4.56 days by month 6. The long-term benefits of galcanezumab were also supported by improvements in other efficacy and functional endpoints. All safety findings were consistent with the known long-term safety profile of galcanezumab; no patients experienced a treatment-related serious adverse event.

conclusionsGalcanezumab was efficacious and well-tolerated in patients with episodic migraine from China, India and Russia, for up to 6 months.

trial registrationClinicalTrisABSTRACT_pals.gov NCT03963232, registered May 24, 2019.

Indexed as

Antibodies, MonoclonalMigraine DisordersAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedgalcanezumabCalcitonin gene-related peptideEpisodic migraine”GalcanezumabHumanized monoclonal antibody

Identifiers

PMID37542222
PMCPMC10401806
OpenAlexW4385581398

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.