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

NCT ID: NCT05452239

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-03-13

Brief Summary

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.

Detailed Description

The total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).

Conditions

Migraine; Medication Overuse Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Eptinezumab

Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: DRUG

Solution for infusion

Placebo

Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.

Group Type: PLACEBO_COMPARATOR

Eptinezumab

Intervention Type: DRUG

Solution for infusion

Placebo

Intervention Type: DRUG

Solution for infusion

Interventions

Eptinezumab

Solution for infusion

Intervention Type: DRUG

Placebo

Solution for infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 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).
• 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.
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

Hôpital Roger Salengro

Lille, Nord, France

CHRU Nantes

Saint-Herblain, Loire-Atlantique, France

Clinical Research of Central Florida - ClinEdge - PPDS

Winter Haven, Florida, United States

Legacy Clinical Solutions: Tandem Clinical Research LLC - Medical Center - Marrero - ClinEdge - PPDS

Marrero, Louisiana, United States

Clinvest - National Ave - Headlands - PPDS

Springfield, Missouri, United States

Dent Neurologic Institute - Amherst

Amherst, New York, United States

Headache Center - Montefiore Medical Center - BRANY - PPDS

The Bronx, New York, United States

Texas Center for Drug Development, Inc

Houston, Texas, United States

Southern Neurology

Kogarah, New South Wales, Australia

Mater Adult Hospital

South Brisbane, Queensland, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Alfred Health

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Danish Headache Center

Glostrup Municipality, Capital, Denmark

Sydvestjysk Sygehus Esbjerg

Esbjerg, , Denmark

CHU de Nice

Nice, Alpes-Maritimes, France

Assistance Publique Hopitaux de Marseille

Marseille, Bouches-du-Rhône, France

Hôpital Pierre-Paul Riquet

Toulouse, Haute-Garonne, France

Centre Hospitalier Annecy Genevois - Site d'Annecy

Pringy, Haute-Savoie, France

Centre Hospitalier Universitaire de Saint Etienne

Saint-Priest-en-Jarez, Pays de la Loire Region, France

Centre Hospitalier Universitaire de Clermont Ferrand -58 Rue Montalembert

Clermont-Ferrand, Puy-de-Dôme, France

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, Rhône, France

AP-HP - Hopital Lariboisiere

Paris, , France

Groupe Hospitalier Paris Saint Joseph

Paris, , France

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center-Gobronidze 10

Tbilisi, , Georgia

Ltd Israel-Georgia Medical Research Clinic Helsicore

Tbilisi, , Georgia

Pineo Medical Ecosystem

Tbilisi, , Georgia

Aversi Clinic LTD

Tbilisi, , Georgia

MediClubGeorgia Ltd

Tbilisi, , Georgia

S. Khechinashvili University Clinic, Ltd.

Tbilisi, , Georgia

Multiprofile Clinic Consilium Medulla

Tbilisi, , Georgia

Klinikverbund Südwest - Kliniken Sindelfingen

Sindelfingen, Baden-Wurttemberg, Germany

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, Hesse, Germany

Studienzentrum Nord-West

Westerstede, Lower Saxony, Germany

Praxis fuer Neurologie, Spezielle Schmerztherapie und Psychotherapie

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, Germany

Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101

Jena, Thuringia, Germany

Universitätsmedizin Greifswald

Greifswald, , Germany

ASL 1 Abruzzo - PO Avezzano

Avezzano, Abruzzo, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Apulia, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2

Napoli, Campania, Italy

IRCCS Istituto delle Scienze Neurologiche - Largo B. Nigrisoli

Bologna, Emilia-Romagna, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, Italy

IRCCS San Raffaele

Rome, Lazio, Italy

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, Italy

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

Perugia, Umbria, Italy

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, , Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2

Palermo, , Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, , Italy

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Akershus Universitetssykehus

Nordbyhagen, Akershus, Norway

Haukeland Universitetssykehus

Bergen, Hordaland, Norway

St. Olav's University Hospital

Trondheim, Sør-Trøndelag, Norway

Oslo Universitetssykehus

Oslo, , Norway

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

C.H. Regional Reina Sofia - PPDS

Córdoba, Córdoba, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Hospital General Universitario Dr. Balmis

Alicante, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, , Spain

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario HM Sanchinarro - CIOCC

Madrid, , Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, , Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Hallands Sjukhus Halmstad

Halmstad, Halland County, Sweden

Skaneuro Privatmottagning

Lund, Skåne County, Sweden

Karolinska Universitetssjukhuset Huddinge

Huddinge, Stockholm County, Sweden

CTC Clinical Trial Consultants AB

Solna, Stockholm County, Sweden

Countries

United States; Australia; Denmark; France; Georgia; Germany; Italy; Netherlands; Norway; Spain; Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-003049-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20007A

Identifier Type: -

Identifier Source: org_study_id