Evidence map›Paper›PMID 35659622›Full record

Trial reportBMC neurology2022

Rapid resolution of migraine symptoms after initiating the preventive treatment eptinezumab during a migraine attack: results from the randomized RELIEF trial.

Jessica Ailani, Peter McAllister, Paul K Winner, George Chakhava, Mette Krog Josiassen, Annika Lindsten, Bjørn Sperling, Anders Ettrup, Roger Cady

Erratum issued Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04152083 (A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

NCT04152083 phase3completednot on this map

A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine

TypeinterventionalSponsorH. Lundbeck A/SRan2019 to 2020Enrolled485ConditionsMigraineArmsEptinezumab, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 3 countries.

Jessica AilaniDepartment of Neurology, Georgetown University Hospital, Washington, DC, USA.
Peter McAllisterNew England Institute for Neurology and Headache, Stamford, CT, USA.
Paul K WinnerPalm Beach Headache Center, West Palm Beach, FL, USA.
George ChakhavaGeorgian Association of Medical Specialties, Multiprofile Clinic Consilium Medulla, D.Tvildiani Medical University, Tbilisi, Georgia.
Mette Krog JosiassenH. Lundbeck A/S, Copenhagen, Denmark.
Annika LindstenH. Lundbeck A/S, Copenhagen, Denmark.
Bjørn SperlingH. Lundbeck A/S, Copenhagen, Denmark.
Anders EttrupH. Lundbeck A/S, Copenhagen, Denmark.
Roger CadyLundbeck LLC, Deerfield, IL, USA. rcady@rkconsults.com.
Lundbeck (Denmark) · DKDavid Tvildiani Medical University · GEDeerfield (United States) · USGeorgetown University · USNew England Institute for Neurology and Headache · USPalm Beach Neurology · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEptinezumab is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody approved for the preventive treatment of migraine. In the phase 3 RELIEF study, eptinezumab resulted in shorter time to headache pain freedom and time to absence of most bothersome symptom (MBS; including nausea, photophobia, or phonophobia) compared with placebo when administered during a migraine attack. The objective of this exploratory analysis was to examine the earliest time points that eptinezumab separated from placebo (P < .05) on headache- and migraine-associated symptoms when administered during a migraine attack.

methodsRELIEF, a multicenter, parallel-group, double-blind trial, occurred from November 7, 2019, through July 8, 2020. Adults considered candidates for preventive treatment were randomized to eptinezumab 100 mg (N = 238) or placebo (N = 242) administered intravenously over 30 min within 1-6 h of migraine onset. Outcome measures included headache pain freedom/relief and absence of MBS, patient's choice of photophobia, phonophobia, or nausea, at regular intervals from 0.5 to 48 h after infusion start. Censoring was applied at time of acute rescue medication use.

resultsAt hour 1, more eptinezumab-treated patients achieved headache pain freedom (9.7%), headache pain relief (38.7%), and absence of MBS (33.2%) versus placebo (4.1%, 26.9%, and 22.1%, respectively; P < .05 all), with separation from placebo (P < .05) through hour 48. Eptinezumab separated from placebo (P < .05) at hour 1 in absence-of-photophobia (29.4% vs 17.0%) and absence-of-phonophobia (41.2% vs 27.2%) and through hour 48. Initial separation from placebo (P < .05) in absence-of-nausea occurred at end-of-infusion (0.5 h; 36.7% vs 25.4%, respectively).

conclusionPreventive treatment with eptinezumab initiated during a migraine attack resulted in more patients achieving headache pain freedom/relief and absence of MBS, with separation from placebo (P < .05) as early as 0.5-1 h following the start of infusion. Rapid resolution of headache- and migraine-associated symptoms by a peripherally acting, intravenously administered antibody suggest a peripheral site of pharmacological action for CGRP blockade.

trial registrationClinicalTrials.gov Identifier: NCT04152083 .

Indexed as

Migraine DisordersPhotophobiaAdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideDouble-Blind MethodHeadacheHumansHyperacusisNauseaTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideeptinezumabCGRPEptinezumabMBSMigraine

Identifiers

PMID35659622
PMCPMC9164335
OpenAlexW4281682773

What OpenQuestion holds

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LicenceCC BY
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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.