Evidence map›Paper›PMID 41395928›Full record

Trial reportEuropean journal of neurology2025

Early and Sustained Shift in Headache Day Frequency Following Eptinezumab Treatment in Adults With Migraine for Whom 2-4 Previous Preventive Treatments Have Failed: A Post Hoc Analysis of the Randomized DELIVER Trial.

Cristina Tassorelli, Amaal J Starling, Susanne F Awad, Xin Ying Lee, Line Pickering Boserup, Divya Asher, Seema Soni-Brahmbhatt, Bjørn Sperling, Peter J Goadsby

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04418765 (Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT04418765 phase3completednot on this map

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

TypeinterventionalSponsorH. Lundbeck A/SRan2020 to 2022Enrolled892ConditionsMigraineArmsEptinezumab, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

9 authors.

Cristina TassorelliDepartment of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy.ORCID 0000-0003-1513-2113
Amaal J StarlingMayo Clinic Arizona, Scottsdale, Arizona, USA.ORCID 0000-0003-1334-1157
Susanne F AwadH. Lundbeck A/S, Copenhagen, Denmark.ORCID 0000-0002-5060-7404
Xin Ying LeeLundbeck LLC, Deerfield, Illinois, USA.ORCID 0000-0002-1102-3756
Line Pickering BoserupH. Lundbeck A/S, Copenhagen, Denmark.ORCID 0000-0002-3062-8881
Divya AsherLundbeck LLC, Deerfield, Illinois, USA.ORCID 0009-0002-3767-7130
Seema Soni-BrahmbhattLundbeck LLC, Deerfield, Illinois, USA.ORCID 0000-0002-4714-6010
Bjørn SperlingH. Lundbeck A/S, Copenhagen, Denmark.
Peter J GoadsbyNIHR King's Clinical Research Facility and Headache Group, King's College London, London, UK.ORCID 0000-0003-3260-5904

Funding

H. Lundbeck A/S
6 · The paper itself

Abstract

backgroundThis post hoc analysis examined the reduction in monthly headache days (MHDs) by frequency category shifts and associated improvements following eptinezumab treatment.

methodsThe DELIVER trial evaluated eptinezumab in adults with migraine for whom 2-4 previous preventive treatments failed. During a 24-week, double-blind, placebo-controlled period followed by a 48-week extension period, participants received IV eptinezumab 100 mg, 300 mg, or placebo every 12 weeks, with all receiving eptinezumab beginning Week 25 (dose-blinded). Participants were categorized by MHD frequency: > 14, 8-14, 4 to < 8, 1 to < 4, 0. MHD category shifts were evaluated in the total population and several subgroups (including participants with > 14 baseline MHDs and early ≥ 50% responders). In participants reporting < 8 MHDs after all doses, the associated changes in headache intensity and disease status were evaluated.

resultsOf randomized participants, 88% (782/890) completed the trial. The percentage of participants randomized initially to eptinezumab who reported < 4 MHDs was 23% (138/592) over Weeks 1-12 and 47% (236/498) over Weeks 61-72; 9% reported 0 MHDs after the final dose. Of participants randomized initially to eptinezumab who shifted from ≥ 8 MHDs at baseline to < 8 over Weeks 1-12, 71% (170/241) reported < 8 MHDs for the rest of the trial; of those who shifted from > 14 to < 8 MHDs, 66% (49/74) reported < 8 MHDs for the rest of the trial. Reduction to < 8 MHDs was associated with robust improvements in headache intensity and disease burden.

conclusionsEptinezumab was associated with sustained reduction in MHD category, with some achieving headache/migraine freedom in patients with a history of preventive treatments that failed.

trial registrationClinicalTrials.gov (identifier: NCT04418765; https://www. CLINICALTRIALS: gov/ct2/show/NCT04418765) and EudraCT (identifier: 2019-004497-25; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25).

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, Humanizedeptinezumabanti‐CGRPeptinezumabheadachemigrainepreventive treatment

Identifiers

PMID41395928
PMCPMC12704021

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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.