A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

NCT04965675 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 19356A2020-001009-222024-510656-13-00
• Study Type: interventional
• Target: 285
• Locations: 11 countries
• Sites: 83

Brief Summary

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Conditions

Chronic Migraine in Children

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12

  Baseline, Weeks 1-12

Secondary Outcomes (13)

• Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12

  Baseline up to Weeks 1-12

• Percentage of Participants With Migraine on the Day After Dosing (Day 1)

  Day 1

• Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12

  Baseline, Weeks 1-12

• Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12

  Baseline up to Weeks 1-12

• Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4

  Baseline up to Weeks 1-4

Study Arms (3)

Eptinezumab 300 mg

EXPERIMENTAL

Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).

Drug: Eptinezumab

Eptinezumab 100 mg

EXPERIMENTAL

Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

Drug: Eptinezumab

Placebo

PLACEBO COMPARATOR

Participants will receive a single IV infusion of placebo matching to eptinezumab.

Drug: Placebo

Interventions

Eptinezumab DRUG

Eptinezumab will be administered per dose and schedule specified in the arm.

Also known as: Vyepti

Eptinezumab 100 mg; Eptinezumab 300 mg

Placebo DRUG

Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
• During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
• During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

You may not qualify if:

• The participant has previously been randomised in this study and exposed to eptinezumab.
• The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
• The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit.
• The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), 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), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (83)

Yale-New Haven Children's Hospital - PIN

New Haven, Connecticut, 06504-8901, United States

COMPLETED

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2916, United States

COMPLETED

Sarkis Clinical Trials - Gainesville

Gainesville, Florida, 32607, United States

COMPLETED

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, 32561-4495, United States

RECRUITING

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Hialeah, Florida, 33012, United States

RECRUITING

Axcess Medical Research - Loxahatchee

Loxahatchee Groves, Florida, 33470-9206, United States

COMPLETED

University of South Florida - 13330 USF Laurel Dr

Tampa, Florida, 33620, United States

RECRUITING

Clinical Integrative Research Center of Atlanta (CIRCAtl)

Atlanta, Georgia, 30328-5574, United States

COMPLETED

University of Kentucky HealthCare (UKHC) Kentucky Clinic

Lexington, Kentucky, 40508-1683, United States

RECRUITING

University of Maryland-Marlene and Stewart Greenebaum Cancer Center

Baltimore, Maryland, 21201-1595, United States

COMPLETED

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104-5131, United States

COMPLETED

Corewell Health - Butterworth Hospital

Grand Rapids, Michigan, 49503-2560, United States

COMPLETED

Dent Neurosciences Research Center Incorporated

Amherst, New York, 14226-1727, United States

COMPLETED

North Suffolk Neurology-Commack

Commack, New York, 11725-2808, United States

COMPLETED

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte

Charlotte, North Carolina, 28211-5027, United States

COMPLETED

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio, 45229-3026, United States

RECRUITING

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

COMPLETED

Road Runner Research Ltd

San Antonio, Texas, 78249-3539, United States

RECRUITING

Children's Specialty Group (CSG)

Norfolk, Virginia, 23510-1021, United States

RECRUITING

Mary Bridge Children's Hospital - PIN

Tacoma, Washington, 98405-4048, United States

COMPLETED

Marshall Health-Marshall University Medical Center

Huntington, West Virginia, 25701-3656, United States

RECRUITING

Hospital Privado de La Comunidad

Mar del Plata, Buenos Aires, B7602CBM, Argentina

COMPLETED

Clínica Privada Independencia

Munro, Buenos Aires, 1605, Argentina

COMPLETED

Sanatorio Allende S.A.

Córdoba, Cordoba, Argentina, X5000JHQ, Argentina

COMPLETED

Hospital de Niños de La Santisima Trinidad

Córdoba-Barrio Crisol, Córdoba Province, X5014AKM, Argentina

RECRUITING

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, 5800, Argentina

RECRUITING

INECO Neurociencias Oroño

Rosario, Santa Fe Province, S2000DTP, Argentina

RECRUITING

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

RECRUITING

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, C1128AAF, Argentina

COMPLETED

Hospital Italiano de Buenos Aires (HIBA) - Centro de Esclerosis Multiple Buenos Aires (CEMBA)

Buenos Aires, C1181ACH, Argentina

COMPLETED

Hospital Britanico de Buenos Aires (HOB)

Buenos Aires, C1280AEB, Argentina

COMPLETED

University of Alberta Hospital (UAH)

Edmonton, Alberta, T6G 2B7, Canada

COMPLETED

Medical Arts Health Research Group - Penticton - PPDS

Penticton, British Columbia, V2A 5L5, Canada

COMPLETED

Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic

Victoria, British Columbia, V8R 1J8, Canada

RECRUITING

The Kids Clinic

Ajax, Ontario, L1Z 0M1, Canada

RECRUITING

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, N6A 5W9, Canada

RECRUITING

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, Apulia, 27100, Italy

COMPLETED

IRCCS Ospedale Pediatrico Bambino Gesu

Rome, Lazio, 00165, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

COMPLETED

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, Lombardy, 27100, Italy

RECRUITING

AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza

Cagliari, Sardinia, 09121, Italy

RECRUITING

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, Tuscany, 27100, Italy

RECRUITING

Istituto Giannina Gaslini IRCCS

Genoa, 16147, Italy

RECRUITING

Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA)

Guadalajara, Jalisco, 44130, Mexico

RECRUITING

Unidad de Investigación en Salud de Chihuahua S.C.

Zapopan, Jalisco, 45150, Mexico

COMPLETED

Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia

Morelia, Michoacán, 58260, Mexico

RECRUITING

Centro de Estudios Clinicos y Especialidades Medicas SC

Monterrey, New Leon, 64620, Mexico

COMPLETED

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, 80050, Mexico

COMPLETED

Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city

México, State of Mexico, 14050, Mexico

COMPLETED

ICARO Investigaciones en Medicina S.A. de C.V.

Chihuahua City, 31000, Mexico

RECRUITING

Instituto de Investigationes Clinicas para la Salud A.C.

Durango, 34000, Mexico

RECRUITING

Clinical Research Institute SC-Mexico

Tepetlacolco, 54055, Mexico

RECRUITING

AthleticoMed Sp. z o.o.

Bydgoszcz, Kuyavian-Pomerania, 85-752, Poland

RECRUITING

Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa

Krakow, Lesser Poland Voivodeship, 30-363, Poland

RECRUITING

Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

RECRUITING

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

RECRUITING

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, 20-412, Poland

RECRUITING

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, 02-172, Poland

RECRUITING

ETG Neuroscience - PPDS

Warsaw, Masovian Voivodeship, 02-677, Poland

RECRUITING

Unidade Local de Saúde de Almada-Seixal, E. P. E (Hospital Garcia de Orta)

Almada, Setúbal District, 2805-267, Portugal

RECRUITING

ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra

Coimbra, 3000-602, Portugal

RECRUITING

ULS de São João, EPE - Hospital de São João

Porto, 4200-319, Portugal

RECRUITING

Childrens University Hospital

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Children and Youth Health Care Institute of Vojvodina

Novi Sad, 21 000, Serbia

RECRUITING

Clinical Center of Vojvodina - Clinic of Psychiatry

Novi Sad, 21000, Serbia

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Madrid, 08035, Spain

COMPLETED

Hospital Universitario Virgen del Rocio - PPDS

Seville, Pontevedra, 41013, Spain

RECRUITING

Hospital Universitario Virgen del Rocio - PPDS

Sevilla, Valencia, 41013, Spain

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

RECRUITING

Izmir City Hospital

Bayraklı, İzmir, 35540, Turkey (Türkiye)

RECRUITING

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, 26480, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Fatih/Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Istanbul University Cerrahpasa Medical Faculty Hospital

Fatih/Istanbul, 34096, Turkey (Türkiye)

COMPLETED

Mersin University Medical Faculty

Mersin, 33169, Turkey (Türkiye)

RECRUITING

Royal Devon and Exeter Hospital NHS Trust - PPDS

Exeter, Devon, EX2 5DW, United Kingdom

COMPLETED

Royal Hospital for Children and Young People - PIN

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

RECRUITING

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

RECRUITING

NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...

Glasgow, North Lanarkshire, G51 4TF, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

RECRUITING

MeSH Terms

Interventions

eptinezumab

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Central Study Contacts

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311; HQ_Medinfo@Lundbeck.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: June 30, 2021
• Primary Completion: September 5, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

TU (5); GB (5); PL (7); PT (3); IT (7); SE (4); US (22); ES (6); AR (10); CA (5); ME (9)