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
Sites (73)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Southern Neurology Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Mater Adult Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Kopfschmerzzentrum Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Completed |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Completed |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Completed |
| Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft Coordinator of this site? Confirm its status | Westerstede | Germany | Completed |
| Esbjerg Og Grindsted Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Completed |
| Hospital General Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Coordinator of this site? Confirm its status | Lleida | Spain | Completed |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 10 | France | Completed |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris Cedex 14 | France | Completed |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Pineo Medical Ecosystem Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| MediClubGeorgia Ltd Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center-Gobronidze 10 Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| S. Khechinashvili University Clinic, Ltd. Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Aversi Clinic LTD Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Multiprofile Clinic Consilium Medulla Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Ltd Israel-Georgia Medical Research Clinic Helsicore Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| University Hospital Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Azienda Sanitaria Locale Avezzano Sulmona L'Aquila Coordinator of this site? Confirm its status | L'aquila | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Completed |
| Neurological Institute Foundation Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Completed |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Completed |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Completed |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Completed |
| Region Halland Coordinator of this site? Confirm its status | Halmstad | Sweden | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Completed |
| Skaneuro AB Coordinator of this site? Confirm its status | Lund | Sweden | Completed |
| CTC Clinical Trial Consultants AB Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| Dent Neurologic Institute - Amherst Coordinator of this site? Confirm its status | Amherst | United States | Unknown status |
| Texas Center for Drug Development, Inc. Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Legacy Clinical Solutions: Tandem Clinical Research LLC - Medical Center - Marrero - ClinEdge - PPDS Coordinator of this site? Confirm its status | Marrero | United States | Unknown status |
| Clinvest - National Ave - Headlands - PPDS Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Headache Center - Montefiore Medical Center - BRANY - PPDS Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Clinical Research of Central Florida - ClinEdge - PPDS Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
Related publications
- 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.J Headache Pain · 2026 · PMID 42288801
- Benefits of eptinezumab on patient-reported disease burden and health-related quality of life in adults with chronic migraine and medication-overuse headache: Results from the placebo-controlled RESOLUTION trial.Cephalalgia · 2026 · PMID 42142011
- Eptinezumab With Patient Education for Chronic Migraine and Medication-Overuse Headache: The Randomized, Placebo-Controlled RESOLUTION Trial.Neurology · 2026 · PMID 41886713
This page is information, not medical advice. Discuss any trial with your doctor.