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

NCT05452239 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 20007A2021-003049-40
• Study Type: interventional
• Target: 608
• Locations: 11 countries
• Sites: 76

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.

Conditions

Migraine; Medication Overuse Headache

Keywords

Eptinezumab; Migraine; Medication overuse headache; Brief educational intervention

Outcome Measures

Primary Outcomes (1)

• Placebo-controlled Period: Change From Baseline in the Number of MMDs at Weeks 1 - 4

  A Migraine Day was defined as a day with a headache if it belonged to any subgroup of headaches that: * lasted ≥30 minutes and met following 2 criteria: - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * lasted ≥30 minutes and participant had an aura with headache. * lasted ≥30 minutes and met 2 of following 3 criteria: - lasted 4 hours; - ≥2 of following characteristics: unilateral location; pulsating quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity; - During headache participant had ≥1 of following: nausea, vomiting, photophobia and phonophobia. * A day with a headache that was successfully treated with a migraine specific treatment. * A day with an aura without a headache with medication taken.

  Baseline, Weeks 1 - 4

Secondary Outcomes (53)

• Placebo-controlled Period: Change From Baseline in MMDs at Weeks 1 to 12

  Baseline, Weeks 1 - 12

• Placebo-controlled Period: Change From Baseline in the Number of Monthly Headache Days (MHDs) at Weeks 1 to 4 and Weeks 1 to 12

  Baseline, Weeks 1 - 4 and Weeks 1 - 12

• Placebo-controlled Period: Percentage of Participants Not Fulfilling the International Classification of Headache Disorders, 3rd Edition (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) Nor Medication Overuse Headache (MOH)

  Weeks 1 - 4 and Weeks 1 - 12

• Placebo-controlled Period: Change From Baseline in Average Daily Pain Assessment Score at Weeks 1 to 2

  Baseline, Weeks 1 - 2

• Placebo-controlled Period: Change From Baseline in Monthly Days With Acute Migraine Medication Use at Weeks 1 to 4 and Weeks 1 to 12

  Baseline, Weeks 1 - 4 and Weeks 1 - 12

Study Arms (2)

Eptinezumab

EXPERIMENTAL

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

Drug: Eptinezumab

Placebo

PLACEBO COMPARATOR

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.

Drug: Eptinezumab; Drug: Placebo

Interventions

Eptinezumab DRUG

Solution for infusion

Eptinezumab; Placebo

Placebo DRUG

Solution for infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (76)

Clinical Research of Central Florida - ClinEdge - PPDS

Winter Haven, Florida, 33880-3053, United States

Location

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

Marrero, Louisiana, 70072-3083, United States

Location

Clinvest - National Ave - Headlands - PPDS

Springfield, Missouri, 65807-6012, United States

Location

Dent Neurologic Institute - Amherst

Amherst, New York, 14226-1727, United States

Location

Headache Center - Montefiore Medical Center - BRANY - PPDS

The Bronx, New York, 10461-2732, United States

Location

Texas Center for Drug Development, Inc

Houston, Texas, 77081, United States

Location

Southern Neurology

Kogarah, New South Wales, 2217, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3052, Australia

Location

Danish Headache Center

Glostrup Municipality, Capital, 2600, Denmark

Location

Sydvestjysk Sygehus Esbjerg

Esbjerg, 6700, Denmark

Location

CHU de Nice

Nice, Alpes-Maritimes, 06000, France

Location

Assistance Publique Hopitaux de Marseille

Marseille, Bouches-du-Rhône, 13385, France

Location

Hôpital Pierre-Paul Riquet

Toulouse, Haute-Garonne, 31000, France

Location

Centre Hospitalier Annecy Genevois - Site d'Annecy

Pringy, Haute-Savoie, 74374, France

Location

CHRU Nantes

Saint-Herblain, Loire-Atlantique, 44800, France

Location

Hôpital Roger Salengro

Lille, Nord, 59000, France

Location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Priest-en-Jarez, Pays de la Loire Region, 42055, France

Location

Centre Hospitalier Universitaire de Clermont Ferrand -58 Rue Montalembert

Clermont-Ferrand, Puy-de-Dôme, 63003, France

Location

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, Rhône, 69500, France

Location

AP-HP - Hopital Lariboisiere

Paris, 75010, France

Location

Groupe Hospitalier Paris Saint Joseph

Paris, 75014, France

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center-Gobronidze 10

Tbilisi, 0101, Georgia

Location

Ltd Israel-Georgia Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Pineo Medical Ecosystem

Tbilisi, 0114, Georgia

Location

Aversi Clinic LTD

Tbilisi, 0160, Georgia

Location

MediClubGeorgia Ltd

Tbilisi, 0160, Georgia

Location

S. Khechinashvili University Clinic, Ltd.

Tbilisi, 0179, Georgia

Location

Multiprofile Clinic Consilium Medulla

Tbilisi, 0186, Georgia

Location

Klinikverbund Südwest - Kliniken Sindelfingen

Sindelfingen, Baden-Wurttemberg, 71065, Germany

Location

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, Hesse, 65929, Germany

Location

Studienzentrum Nord-West

Westerstede, Lower Saxony, 26655, Germany

Location

Praxis fuer Neurologie, Spezielle Schmerztherapie und Psychotherapie

Essen, North Rhine-Westphalia, 45133, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, 01307, Germany

Location

Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101

Jena, Thuringia, 07747, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

ASL 1 Abruzzo - PO Avezzano

Avezzano, Abruzzo, 67051, Italy

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Apulia, 70124, Italy

Location

Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2

Naples, Campania, 80138, Italy

Location

IRCCS Istituto delle Scienze Neurologiche - Largo B. Nigrisoli

Bologna, Emilia-Romagna, 40139, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, 00128, Italy

Location

IRCCS San Raffaele

Rome, Lazio, 00163, Italy

Location

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, 00168, Italy

Location

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, 20127, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

Perugia, Umbria, 06129, Italy

Location

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, 41100, Italy

Location

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

Palermo, 90127, Italy

Location

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, 27100, Italy

Location

Leids Universitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

Location

Akershus Universitetssykehus

Nordbyhagen, Akershus, 1474, Norway

Location

Haukeland Universitetssykehus

Bergen, Hordaland, 5021, Norway

Location

St. Olav's University Hospital

Trondheim, Sør-Trøndelag, 7006, Norway

Location

Oslo Universitetssykehus

Oslo, Norway

Location

Hospital Puerta del Mar

Cadiz, Cádiz, 11009, Spain

Location

C.H. Regional Reina Sofia - PPDS

Córdoba, Córdoba, 14004, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8035, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario HM Sanchinarro - CIOCC

Madrid, 28050, Spain

Location

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47010, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hallands Sjukhus Halmstad

Halmstad, Halland County, 301 85, Sweden

Location

Skaneuro Privatmottagning

Lund, Skåne County, 227 33, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Huddinge, Stockholm County, 141 52, Sweden

Location

CTC Clinical Trial Consultants AB

Solna, Stockholm County, 176 64, Sweden

Location

Related Publications (1)

• Jensen RH, Lundqvist C, Schytz HW, Tassorelli C, Vernieri F, Lanteri-Minet M, Terwindt GM, Blumenfeld A, Tepper SJ, Josiassen MK, Jansson G, Ettrup A, Mittoux A, Lipton RB. Eptinezumab With Patient Education for Chronic Migraine and Medication-Overuse Headache: The Randomized, Placebo-Controlled RESOLUTION Trial. Neurology. 2026 Apr 28;106(8):e214863. doi: 10.1212/WNL.0000000000214863. Epub 2026 Mar 26.

  PMID: 41886713 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders, Secondary

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Email contact via H. Lundbeck A/S

  HQ_Medinfo@Lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: July 1, 2022
• Primary Completion: October 22, 2024
• Study Completion: March 13, 2025
• Last Updated: January 29, 2026
• Results First Posted: December 4, 2025

Record last verified: 2026-01

Locations

DE (8); SE (4); US (6); FR (11); NO (4); ES (14); DK (2); AU (5); NL (1); IT (14); GE (7)