Evidence map›Paper›PMID 32050782›Full record

Trial reportCephalalgia : an international journal of headache2020

Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment.

David W Dodick, Peter J Goadsby, Christian Lucas, Rigmor Jensen, Jennifer N Bardos, James M Martinez, Chunmei Zhou, Sheena K Aurora, Jyun Yan Yang, Robert R Conley and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cephalalgia : an international journal of headache, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02438826 (A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of), which is not on this map. Cited by 61 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 4 pooled it
14.7field-weighted citation impact, top 1% 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.

NCT02438826 phase3completednot on this map

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of : Galcanezumab (LY2951742) With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2019Enrolled240ConditionsChronic Cluster HeadacheArmsGalcanezumab 300 mg, Placebo
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 4 syntheses or guidelines pooled it, 149 citations in OpenAlex.

  1. Efficacy and safety of CGRP monoclonal antibodies for cluster headache: a systematic review and network meta-analysis of randomized controlled trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Pooled it
  2. Pooled it
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  5. Trial
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  9. Article
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  11. Hallmarks of primary headache: part 3 - cluster headache.The journal of headache and pain · 2025
    Review
  12. Article
  13. 15. Cluster Headache.Pain practice : the official journal of World Institute of Pain · 2025
    Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Observational
  19. Review
  20. Article

1 more citing papers are in PubMed but not listed here.

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 6 institutions in 4 countries.

David W DodickDepartment of Neurology, Mayo Clinic, Phoenix, AZ, USA.
Peter J GoadsbyNIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.ORCID 0000-0003-3260-5904
Christian LucasPain Clinic, Department of Neurosurgery, Hôpital Salengro, CHU de Lille, Lille, France.
Rigmor JensenDanish Headache Center, Rigshospitalet-Glostrup, Glostrup, Denmark.
Jennifer N BardosEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
James M MartinezEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Chunmei ZhouEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Sheena K AuroraEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Jyun Yan YangEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Robert R ConleyEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Tina OakesEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
Eli Lilly (United States) · USCentre Hospitalier Universitaire de Lille · FRGlostrup Hospital · DKMayo Clinic Hospital · USUniversity of California, San Francisco · USUniversity of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo report efficacy and safety of galcanezumab in adults with chronic cluster headache.

backgroundGalcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide and inhibits its biological activity.

methodsThis study comprised a prospective baseline period, a 12-week double-blind, placebo-controlled treatment period, and a 52-week open-label period. Up to six protocol-specified concomitant preventive medications were allowed if patients were on a stable dose for 2 months prior to the prospective baseline period. Patients were randomized 1:1 to monthly subcutaneous galcanezumab (300 mg) or placebo. The primary endpoint was overall mean change from baseline in weekly attack frequency with galcanezumab compared to placebo. Key secondary endpoints were ≥50% response rate and percentage of patients meeting sustained response. Results from the double-blind treatment period are reported.

resultsA total of 237 patients were randomized and treated (120 placebo; 117 galcanezumab). At baseline, the mean age was 45 years and 63% were using ≥1 preventive drug. The primary endpoint was not met; mean change in weekly attack frequency was -4.6 placebo versus -5.4 galcanezumab (

conclusionTreatment with galcanezumab 300 mg did not achieve its primary and key secondary endpoints. This study underscores the potential distinct biology of cCH as well as the significant unmet need for safe, effective, and well-tolerated preventive treatment. The safety profile of galcanezumab in cCH is consistent with that observed in trials of episodic CH and migraine.

trial registrationNCT02438826; https://www.clinicaltrials.gov/ct2/show/NCT02438826.

Indexed as

AdultAnalgesicsAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideCluster HeadacheDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAnalgesicsAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptidegalcanezumabCGRPchronic cluster headacheGalcanezumabhumanized monoclonal antibodyLY2951742

Identifiers

PMID32050782
PMCPMC7787002
OpenAlexW3006539195

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.