TY - JOUR

T1 - Adding eptinezumab to brief patient education to treat chronic migraine and medication-overuse headache

T2 - Protocol for RESOLUTION—A phase 4, multinational, randomized, double-blind, placebo-controlled study

AU - Jensen, Rigmor H.

AU - Schytz, Henrik Winther

AU - Tassorelli, Cristina

AU - Terwindt, Gisela M.

AU - Carlsen, Louise N.

AU - Mittoux, Aurélia

AU - Østerberg, Ole

AU - Lipton, Richard B.

AU - Tepper, Stewart J.

AU - Blumenfeld, Andrew

AU - Lundqvist, Christofer

N1 - Publisher Copyright: Copyright © 2023 Jensen, Schytz, Tassorelli, Terwindt, Carlsen, Mittoux, Østerberg, Lipton, Tepper, Blumenfeld and Lundqvist.

PY - 2023

Y1 - 2023

N2 - 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; n = 285) or BEI and placebo (n = 285), in a 1:1 ratio. The primary endpoint is the change from baseline in monthly migraine days over weeks 1–4. Secondary and exploratory endpoints will assess monthly migraine days over weeks 1–12, MOH remission, transition from chronic to episodic migraine, health-related quality of life, work productivity, and the safety and tolerability of eptinezumab in this patient population. 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.

AB - 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; n = 285) or BEI and placebo (n = 285), in a 1:1 ratio. The primary endpoint is the change from baseline in monthly migraine days over weeks 1–4. Secondary and exploratory endpoints will assess monthly migraine days over weeks 1–12, MOH remission, transition from chronic to episodic migraine, health-related quality of life, work productivity, and the safety and tolerability of eptinezumab in this patient population. 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.

KW - Brief Educational Intervention

KW - eptinezumab

KW - medication-overuse headache

KW - migraine

KW - preventive medicine

KW - protocols and guidelines

UR - http://www.scopus.com/inward/record.url?scp=85150052385&partnerID=8YFLogxK

U2 - 10.3389/fneur.2023.1114654

DO - 10.3389/fneur.2023.1114654

M3 - Journal article

C2 - 36908606

AN - SCOPUS:85150052385

VL - 14

JO - Frontiers in Neurology

JF - Frontiers in Neurology

SN - 1664-2295

M1 - 1114654

ER -