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NCT05452239CompletedPhase 4

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications. Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
608 (actual)
First submitted
6 Jul 2022
Start date
1 Jul 2022
Primary completion date
22 Oct 2024
Lead sponsor
H. Lundbeck A/S
Diseases
Migraine
NCT number
NCT05452239
EU CT number
2024-510729-24-00
EudraCT number
2021-003049-40

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 608
  • From 1 Jul 2022 to the primary completion date, 22 Oct 2024
  • 73 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.

Other illness

  • The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
  • The participant has a diagnosis of acute or active temporomandibular disorders.
  • The participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
    • Other inclusion and exclusion criteria may apply.

Other

  • The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).

Who the study is looking for

  • The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
  • The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
  • The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
  • The participant has had an onset of migraine diagnosis at ≤50 years of age.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (73)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Austin Hospital
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HeidelbergAustraliaUnknown status
Southern Neurology
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KogarahAustraliaUnknown status
Alfred Health
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MelbourneAustraliaUnknown status
Royal Melbourne Hospital
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ParkvilleAustraliaUnknown status
Mater Adult Hospital
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South BrisbaneAustraliaUnknown status
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Coordinator of this site? Confirm its status
DresdenGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Kopfschmerzzentrum
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Frankfurt am MainGermanyCompleted
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyCompleted
Universitaetsklinikum Jena KöR
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JenaGermanyCompleted
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
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WesterstedeGermanyCompleted
Esbjerg Og Grindsted Sygehus
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EsbjergDenmarkCompleted
Rigshospitalet
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GlostrupDenmarkCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario Puerta del Mar
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CadizSpainCompleted
Hospital General Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
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LleidaSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Hospital Clínico Universitario de Valladolid
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ValladolidSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted
Hospices Civils de Lyon
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BronFranceCompleted
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Centre Hospitalier Regional De Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 10FranceCompleted
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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Paris Cedex 14FranceCompleted
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Pineo Medical Ecosystem
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
MediClubGeorgia Ltd
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center-Gobronidze 10
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
S. Khechinashvili University Clinic, Ltd.
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TbilisiGeorgiaUnknown status
Aversi Clinic LTD
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TbilisiGeorgiaUnknown status
Multiprofile Clinic Consilium Medulla
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TbilisiGeorgiaUnknown status
Ltd Israel-Georgia Medical Research Clinic Helsicore
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TbilisiGeorgiaUnknown status
University Hospital Consorziale Policlinico
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BariItalyCompleted
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
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L'aquilaItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyCompleted
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyCompleted
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyCompleted
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyCompleted
Neurological Institute Foundation Casimiro Mondino
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PaviaItalyCompleted
Hospital Santa Maria Della Misericordia
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PerugiaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyCompleted
Irccs San Raffaele Roma S.r.l.
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RomeItalyCompleted
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsCompleted
Helse Bergen HF
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BergenNorwayCompleted
Akershus University Hospital
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LoerenskogNorwayCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
St. Olavs hospital HF
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TrondheimNorwayCompleted
Region Halland
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HalmstadSwedenCompleted
Karolinska University Hospital
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HuddingeSwedenCompleted
Skaneuro AB
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LundSwedenCompleted
CTC Clinical Trial Consultants AB
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SolnaSwedenCompleted
Dent Neurologic Institute - Amherst
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AmherstUnited StatesUnknown status
Texas Center for Drug Development, Inc.
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HoustonUnited StatesUnknown status
Legacy Clinical Solutions: Tandem Clinical Research LLC - Medical Center - Marrero - ClinEdge - PPDS
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MarreroUnited StatesUnknown status
Clinvest - National Ave - Headlands - PPDS
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SpringfieldUnited StatesUnknown status
Headache Center - Montefiore Medical Center - BRANY - PPDS
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The BronxUnited StatesUnknown status
Clinical Research of Central Florida - ClinEdge - PPDS
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Winter HavenUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.