Evidence map›Paper›PMID 36927366›Full record

Observational studyThe journal of headache and pain2023

Galcanezumab effects on incidence of headache after occurrence of triggers, premonitory symptoms, and aura in responders, non-responders, super-responders, and super non-responders.

Sait Ashina, Agustin Melo-Carrillo, Ajayi Toluwanimi, Nicolas Bolo, Edina Szabo, David Borsook, Rami Burstein

Registry-linked trialOpen access · goldFull text readObservational Study
In one paragraph

Observational study 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 NCT04271202 (Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
8.2field-weighted citation impact, top 2% 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.

NCT04271202 phase4completednot on this map

Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2020 to 2023Enrolled64ConditionsChronic MigraineArmsEmgality 120 MG in 1 ML Prefilled Syringe
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
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  16. Molecular Mechanisms of Migraine: Nitric Oxide Synthase and Neuropeptides.International journal of molecular sciences · 2023
    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

7 authors at 2 institutions in 1 country.

Sait AshinaDepartment of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Agustin Melo-CarrilloDepartment of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Ajayi ToluwanimiClinical Research Center, Beth Israel Deaconess Medical Boston, Boston, MA, USA.
Nicolas BoloDepartments of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Edina SzaboDepartment of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
David Borsook *Departments of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Rami Burstein *Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA. rburstei@bidmc.harvard.edu.
Harvard University · USBeth Israel Deaconess Medical Center · US

Funding

Photophobia during migraine: sensory, autonomic and emotional responses to lightR37NS079678 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BURSTEIN, RAMI · 2012 to 2018
$3.1M
Cortical Mechanisms of Headache: Beyond CSDR01NS094198 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BURSTEIN, RAMI · 2016 to 2020
$1.9M
Characterization of sleep behavior in a rodent model of headacheR21NS106345 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI STRASSMAN, ANDREW MARK · 2018 to 2019
$498k
Eli Lilly and Company 32939NINDS NIH HHS R01 NS094198NINDS NIH HHS R21 NS106345NINDS NIH HHS R37 NS079678
6 · The paper itself

Abstract

backgroundThe goal of this observational, open-label, cohort study was to determine whether prophylactic migraine treatment with galcanezumab, a peripherally acting drug, alters the incidence of premonitory symptoms, and/or occurrence of headache after exposure to triggers or aura episodes in treatment-responders (≥ 50% reduction in monthly migraine days [MMD]), super-responders (≥ 70%), non-responders (< 50%) and super non-responders (< 30%).

methodsParticipants were administered electronic daily headache diaries to document migraine days and associated symptoms one month before and during the three months of treatment. Questionnaires were used to identify conscious prodromal and trigger events that were followed by headache prior to vs. after 3 months of treatment.

resultsAfter 3 months of galcanezumab treatment, (a) the incidence of premonitory symptoms that were followed by headache decreased by 48% in the 27 responders vs. 28% in the 19 non-responders, and by 50% in the 11 super-responders vs. 12% in the 8 super non-responders; (b) the incidence of visual and sensory aura that were followed by headache was reduced in responders, non-responders, and super-responders, but not in super non-responders; (c) the number of triggers followed by headache decreased by 38% in responders vs. 13% in non-responders, and by 31% in super-responders vs. 4% in super non-responders; and (d) some premonitory symptoms (e.g., cognitive impairment, irritability, fatigue) and triggers (e.g., stress, sleeping too little, bright light, aura) were followed by headache only in super non-responders.

conclusionsMechanistically, these findings suggest that even a mild decrease in migraine frequency is sufficient to partially reverse the excitability and responsivity of neurons involved in the generation of certain triggers and potentially premonitory symptoms of migraine.

trial registrationClinicalTrials.gov: NCT04271202. Registration date: February 10, 2020.

Indexed as

EpilepsyMigraine DisordersAntibodies, Monoclonal, HumanizedCohort StudiesHeadacheHumansIncidenceTreatment OutcomeAntibodies, Monoclonal, HumanizedgalcanezumabCentral sensitizationCGRP monoclonal antibodiesHypothalamusMigraineTrigeminal

Identifiers

PMID36927366
PMCPMC10018924
OpenAlexW4327683975

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read124
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.