Evidence map›Paper›PMID 35130832›Full record

Trial reportThe journal of headache and pain2022

Eptinezumab treatment initiated during a migraine attack is associated with meaningful improvement in patient-reported outcome measures: secondary results from the randomized controlled RELIEF study.

Peter McAllister, Paul K Winner, Jessica Ailani, Dawn C Buse, Richard B Lipton, George Chakhava, Mette Krog Josiassen, Annika Lindsten, Lahar Mehta, Anders Ettrup and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
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 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 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 17% 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

7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Drugs for Migraine Prophylaxis.Deutsches Arzteblatt international · 2026
    Review
  7. 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

11 authors at 8 institutions in 3 countries.

Peter McAllisterNew England Institute for Neurology and Headache, Stamford, CT, USA.
Paul K WinnerPalm Beach Headache Center, West Palm Beach, FL, USA.
Jessica AilaniDepartment of Neurology, Georgetown University Hospital, Washington, DC, USA.
Dawn C BuseAlbert Einstein College of Medicine, Bronx, NY, USA.
Richard B LiptonAlbert Einstein College of Medicine, Bronx, NY, USA.
George ChakhavaMultiprofile Clinic Consilium Medulla, Georgian Association of Medical Specialties, David Tvildiani Medical University, Tbilisi, Georgia.
Mette Krog JosiassenH. Lundbeck A/S, Copenhagen, Denmark.
Annika LindstenH. Lundbeck A/S, Copenhagen, Denmark.
Lahar MehtaLundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.
Anders EttrupH. Lundbeck A/S, Copenhagen, Denmark.
Roger CadyLundbeck LLC, Deerfield, IL, USA. rcady@rkconsults.com.
Lundbeck (Denmark) · DKAlbert Einstein College of Medicine · USDavid Tvildiani Medical University · GEDeerfield (United States) · USGeorgetown University · USNew England Institute for Neurology and Headache · USNova Southeastern University · USSeagen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDemonstrating therapeutic value from the patient perspective is important in patient-centered migraine management. The objective of this study was to investigate the impact of eptinezumab, a preventive migraine treatment, on patient-reported headache impact, acute medication optimization, and perception of disease change when initiated during a migraine attack.

methodsRELIEF was a randomized, double-blind, placebo-controlled trial conducted between 2019 and 2020 in adults with ≥1-year history of migraine and 4-15 migraine days per month in the 3 months prior to screening. Patients were randomized (1:1) to a 30-min infusion of eptinezumab 100 mg or placebo within 1-6 h of a qualifying migraine attack onset. The 6-item Headache Impact Test (HIT-6) and 6-item Migraine Treatment Optimization Questionnaire (mTOQ-6) were administered at baseline and week 4, and the Patient Global Impression of Change (PGIC) at week 4. A post hoc analysis of these measures was conducted in patients who reported headache pain freedom at 2 h after infusion start.

resultsOf 480 patients enrolled and treated, 476 completed the study and are included in this analysis. Mean baseline HIT-6 total scores indicated severe headache impact (eptinezumab, 65.1; placebo, 64.8). At week 4, the eptinezumab-treated group demonstrated clinically meaningful improvement in HIT-6 total score compared with placebo (mean change from baseline: eptinezumab, - 8.7; placebo, - 4.5; mean [95% CI] difference from placebo: - 4.2 [- 5.75, - 2.63], P < .0001), with greater reductions in each item score vs placebo (P < .001 all comparisons). Change in HIT-6 total score in the subgroup with 2-h headache pain freedom was - 13.8 for the eptinezumab group compared with - 4.9 for the placebo group. mTOQ-6 total score mean change from baseline favored eptinezumab (change, 2.1) compared with placebo (1.2; mean [95% CI] difference: 0.9 [0.3, 1.5], P < .01). More eptinezumab-treated patients rated PGIC as much or very much improved than placebo patients (59.3% vs 25.9%).

conclusionsWhen administered during a migraine attack, eptinezumab significantly improved patient-reported outcomes after 4 weeks compared with placebo, with particularly pronounced effects in patients reporting headache pain freedom at 2 h after infusion start.

trial registrationClinicalTrials.gov Identifier: NCT04152083 . November 5, 2019.

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersAdultDouble-Blind MethodHumansPatient Reported Outcome MeasuresTreatment OutcomeAntibodies, Monoclonal, HumanizedeptinezumabCGRPEptinezumabMBSMigraine

Identifiers

PMID35130832
PMCPMC8903522
OpenAlexW4210883621

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.