Evidence map›Paper›PMID 36908606›Full record

ArticleFrontiers in neurology2023

Adding eptinezumab to brief patient education to treat chronic migraine and medication-overuse headache: Protocol for RESOLUTION-A phase 4, multinational, randomized, double-blind, placebo-controlled study.

Rigmor H Jensen, Henrik Winther Schytz, Cristina Tassorelli, Gisela M Terwindt, Louise N Carlsen, Aurélia Mittoux, Ole Østerberg, Richard B Lipton, Stewart J Tepper, Andrew Blumenfeld and 1 more

Abstract read
In one paragraph

Article in Frontiers in neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. LOTUS Software to Process Wearable EmbracePlus Data.Sensors (Basel, Switzerland) · 2024
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  6. 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.

Rigmor H JensenDepartment of Neurology, Danish Headache Center, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.
Henrik Winther SchytzDepartment of Neurology, Danish Headache Center, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.
Cristina TassorelliDepartment of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
Gisela M TerwindtDepartment of Neurology, Leiden University Medical Centre, Leiden, Netherlands.
Louise N CarlsenDepartment of Neurology, Danish Headache Center, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.
Aurélia MittouxH. Lundbeck, Copenhagen, Denmark.
Ole ØsterbergH. Lundbeck, Copenhagen, Denmark.
Richard B LiptonDepartment of Neurology, Albert Einstein College of Medicine, New York, NY, United States.
Stewart J TepperDepartment of Neurology, Dartmouth Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, United States.
Andrew BlumenfeldThe Los Angeles Headache Center, Los Angeles, CA, United States.
Christofer LundqvistDepartments of Neurology and Health Services Research, Akershus University Hospital, Lørenskog, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Migraine is a highly prevalent and disabling neurological disease. Excessive use of acute medications can lead to medication-overuse headache (MOH), occurring when a patient experiences an increasing number of headache and migraine days, despite taking greater amounts of acute medication. To treat MOH, a preventive migraine treatment and/or withdrawal of the overused medication(s) are advised. Brief Educational Intervention (BEI) has been shown to be an effective tool with promising results for MOH. Here, we report the design of a clinical trial that aims to evaluate the efficacy of eptinezumab, an anti-calcitonin gene-related peptide preventive migraine treatment, as an add-on to BEI for treatment of MOH in those with chronic migraine. Methods and analysis: RESOLUTION will be a phase 4, multi-national, randomized, double-blind, placebo-controlled study. This study will enroll approximately 570 participants with dual diagnoses of chronic migraine and MOH. Eligible patients will be randomly allocated to one of two treatment groups, BEI and eptinezumab (100 mg; Ethics and dissemination: This study will be conducted in accordance with good clinical practice. All patients will be fully informed about the study, including the risks and benefits of participation, and all participants will provide informed consent for participation in the trial and dissemination of results.

Indexed as

Brief Educational Interventioneptinezumabmedication-overuse headachemigrainepreventive medicineprotocols and guidelines

Identifiers

PMID36908606
PMCPMC9994537

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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.