Trial reportNeurology2026
Eptinezumab With Patient Education for Chronic Migraine and Medication-Overuse Headache: The Randomized, Placebo-Controlled RESOLUTION Trial.
Trial report in Neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05452239 (Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache), which is not on this map. Cited by 2 papers.
What it found
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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.
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.
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache
Who cites it
2 citing papers in PubMed.
- Efficacy and safety of eptinezumab in adults with chronic migraine and medication-overuse headache who also received patient education: 24-week results of the randomized RESOLUTION trial.The journal of headache and pain · 2026Trial
- Twelve-months prospective real-world assessment of effectiveness and safety of eptinezumab in migraine patients difficult-to-treat and naïve to CGRP monoclonal antibodies: results of the French FHU INOVPAIN registry.The journal of headache and pain · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesMedication-overuse headache (MOH) commonly co-occurs with and complicates chronic migraine (CM). This trial evaluated efficacy and safety of eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody for migraine prevention-combined with a standardized brief educational intervention (BEI)-in adults with CM and MOH. We report results from the 12-week placebo-controlled period, of which weeks 1-4 was the primary time point.
methodsThe phase 4, double-blind, placebo-controlled RESOLUTION trial was conducted at 76 specialist clinics across 11 countries. Eligible participants were adults diagnosed with CM and MOH and were randomized 1:1 to eptinezumab 100 mg IV with BEI or placebo IV with BEI. The primary end point was mean change from baseline in monthly migraine days (MMDs; weeks 1-4). Key secondary end points (multiplicity-controlled) included changes from baseline in monthly headache days, monthly days with acute migraine medication use, and average daily pain, as well as fulfillment of thresholds defining CM and MOH. Treatment-emergent adverse events (TEAEs) were assessed.
resultsBetween July 2022 and March 2025, 608 participants were randomized, and 596 (98%) completed the placebo-controlled period. Of 604 participants treated, 517 (86%) were female and 87 (14%) were male; the mean age was 45.5 years (SD 12.0). The primary end point, mean change from baseline in MMDs (weeks 1-4), favored eptinezumab with BEI vs placebo with BEI (-6.9 vs -3.7; group difference -3.2; 95% CI -4.2 to -2.2; DISCUSSION: In adults with CM and MOH who also received patient education, eptinezumab was statistically superior to placebo on the primary and all key secondary end points, reducing disease burden as early as weeks 1-4 and throughout weeks 1-12. Eptinezumab was generally well tolerated, with no new safety signals identified. Together, data from this trial indicate that eptinezumab in combination with patient education is an effective treatment for reducing disease burden in patients living with CM complicated by medication overuse. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT05452239 (clinicaltrials.gov/study/NCT05452239); EudraCT Number: 2021-003049-40 (clinicaltrialsregister.eu/ctr-search/search?query=2021-003049-40); EU CTR Number: 2024-510729-24-00 (euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-510729-24-00). EudraCT Number obtained: May 25, 2021. ClinicalTrials.gov Identifier obtained: July 6, 2022. First patient enrolled: July 1, 2022. CLASSIFICATION OF EVIDENCE: This clinical trial provides Class I evidence that eptinezumab with patient education is superior to placebo with patient education in reducing MMDs in adults with CM and MOH.
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