A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine (PROSPECT-2)

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Migraine in Children
• Intervention / Treatment: Drug: Eptinezumab; Drug: Placebo

Detailed Description

The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.

• Study Type: Interventional
• Enrollment (Estimated): 285
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Email contact via H. Lundbeck A/S; Phone Number: +45 36301311; Email: HQ_Medinfo@Lundbeck.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1128AAF
    • Completed
    • Expertia S.A- Mautalen Salud e Investigación
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, 7603
      • Completed
      • Hospital Privado de La Comunidad
    • Munro, Buenos Aires, Argentina, 1605
      • Completed
      • Clinica Privada Independencia
  • Ciudad Autónoma de BuenosAires
    • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1280
      • Completed
      • Hospital Británico de Buenos Aires
    • Ciudad Autónoma Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1181ACH
      • Completed
      • Hospital Italiano de Buenos Aires
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5000JHGQ
      • Completed
      • Sanatorio Allende S.A
    • Córdoba, Córdoba Province, Argentina, X5014AKM
      • Recruiting
      • Hospital de Niños de la Santísima Trinidad
    • Río Cuarto, Córdoba Province, Argentina, 5800
      • Recruiting
      • Instituto Medico Rio Cuarto
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000DTP
      • Recruiting
      • INECO Neurociencias Oroño
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
      • Recruiting
      • Centro de Investigaciones Médicas Tucumán - PPDS
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R7
      • Completed
      • University of Alberta
  • British Columbia
    • Penticton, British Columbia, Canada, V2A 5L5
      • Completed
      • Medical Arts Health Research Group - Penticton - PPDS
    • Victoria, British Columbia, Canada, V8R 1J8
      • Recruiting
      • Vancouver Island Health Authority
  • Ontario
    • Ajax, Ontario, Canada, L1Z 0M1
      • Recruiting
      • The Kids Clinic
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre -800 Commissioners Rd E
• Italy
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Completed
      • Azienda Ospedaliero Universitaria Consorziale Policlinico
  • Lazio
    • Rome, Lazio, Italy, 00165
      • Recruiting
      • Ospedale Pediatrico Bambino Gesù IRCCS
  • Liguria
    • Genoa, Liguria, Italy, 16147
      • Recruiting
      • IRCCS Istituto Giannina Gaslini
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Ospedale San Raffaele S.r.l.
    • Milan, Lombardy, Italy, 20133
      • Completed
      • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
  • Sardinia
    • Cagliari, Sardinia, Italy, 09121
      • Recruiting
      • AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • Recruiting
      • Azienda Ospedaliero Universitaria A Meyer (Duplicate)
• Mexico
  • Chihuahua City, Mexico, 31000
    • Recruiting
    • ICARO Investigaciones en Medicina, S.A de C.V
  • Culiacán Sinaloa, Mexico, 80020
    • Completed
    • Neurociencias Estudios Clinicos S.C.
  • Durango, Mexico, 34000
    • Recruiting
    • Instituto de Investigationes Clinicas para la Salud A.C.
  • Mexico City, Mexico, 14050
    • Completed
    • Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
  • Monterrey, Mexico, 64620
    • Completed
    • Centro de Estudios Clinicos Y Especialidades Medicas SC
  • México, Mexico, 54055
    • Recruiting
    • Clinical Research Institute SC-Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44700
      • Recruiting
      • Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
    • Zapopan, Jalisco, Mexico, 45150
      • Completed
      • Unidad de Investigacion en Salud de Chihuahua S.C.
  • Michoacán
    • Morelia, Michoacán, Mexico, 58260
      • Recruiting
      • Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
      • Recruiting
      • AthleticoMed
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-363
      • Recruiting
      • Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
    • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
      • Recruiting
      • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
      • Recruiting
      • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-412
      • Recruiting
      • ETG Lublin - PPDS
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-172
      • Recruiting
      • MTZ Clinical Research Powered by PRATIA - PPDS
    • Warsaw, Masovian Voivodeship, Poland, 02-677
      • Recruiting
      • ETG Neuroscience - PPDS
• Portugal
  • Coimbra, Portugal, 3000-602
    • Recruiting
    • ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
  • Porto, Portugal, 4200-319
    • Recruiting
    • ULS de São João, EPE - Hospital de São João
  • Setúbal District
    • Almada, Setúbal District, Portugal, 2805-267
      • Recruiting
      • ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Childrens University Hospital
  • Kragujevac, Serbia, 34000
    • Recruiting
    • University Clinical Center Kragujevac
  • Novi Sad, Serbia, 21 000
    • Recruiting
    • Children and Youth Health Care Institute of Vojvodina
  • Novi Sad, Serbia, 21 000
    • Recruiting
    • Clinical Centre of Vojvodina
• Spain
  • Barcelona, Spain, 8025
    • Recruiting
    • Hospital Universitario Vall d'Hebron - PPDS
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28036
    • Completed
    • Instituto del Sueño
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio - PPDS
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36213
      • Recruiting
      • CHUVI - H.U. Alvaro Cunqueiro
• Turkey (Türkiye)
  • Eskişehir, Turkey (Türkiye), 26480
    • Recruiting
    • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
  • Fatih/Istanbul, Turkey (Türkiye), 34093
    • Recruiting
    • Istanbul Üniversitesi, Istanbul Tip Fakültesi, Nör
  • Fatih/Istanbul, Turkey (Türkiye), 34096
    • Completed
    • Istanbul University Cerrahpasa Medical Faculty Hospital
  • Izmir, Turkey (Türkiye), 35540
    • Recruiting
    • İzmir City Hospital
  • Mersin, Turkey (Türkiye), 33169
    • Recruiting
    • Mersin University Medical Faculty
• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Completed
      • Royal Devon and Exeter Hospital NHS Trust - PPDS
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G51 4TF
      • Recruiting
      • Queen Elizabeth University Hospital - PPDS
  • London, City of
    • London, London, City of, United Kingdom, WC1N 3JH
      • Recruiting
      • Great Ormond Street Hospital - PPDS
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH16 4TJ
      • Recruiting
      • Royal Hospital for Children and Young People - PIN
  • Norfolk
    • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
      • Recruiting
      • James Paget University Hospitals NHS Foundation Trust
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06504-8901
      • Recruiting
      • Yale-New Haven Children's Hospital - PIN
    • Stamford, Connecticut, United States, 06905-1206
      • Recruiting
      • Ki Health Partners LLC DBA New England Institute for Clinical Research
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010-2916
      • Completed
      • Children's National Medical Center
  • Florida
    • Gulf Breeze, Florida, United States, 32561-4458
      • Recruiting
      • NW FL Clinical Research Group, LLC
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • AGA Clinical Trials - Hialeah - 4980 W 10th Ave
    • Loxahatchee Groves, Florida, United States, 33470-9272
      • Completed
      • Axcess Medical Research
    • Tampa, Florida, United States, 33612-6601
      • Recruiting
      • University Of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30328-6191
      • Recruiting
      • Clinical Integrative Research Center of Atlanta
  • Kentucky
    • Lexington, Kentucky, United States, 40508-1683
      • Recruiting
      • University of Kentucky HealthCare (UKHC) Kentucky Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
  • Michigan
    • Ann Arbor, Michigan, United States, 48104-5131
      • Completed
      • Michigan Head Pain and Neurological Institute
    • East Lansing, Michigan, United States, 48824-7015
      • Completed
      • Michigan State University - Department of Neurology
    • Grand Rapids, Michigan, United States, 49503-2560
      • Recruiting
      • Corewell Health Butterworth Hospital
  • New York
    • Amherst, New York, United States, 14226-1746
      • Completed
      • Dent Neurosciences Research Center Incorporated
    • Commack, New York, United States, 11725-2808
      • Recruiting
      • North Suffolk Neurology-Commack
  • North Carolina
    • Charlotte, North Carolina, United States, 28211-5027
      • Completed
      • OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3026
      • Recruiting
      • Cincinnati Children's Hospital Medical Center - PIN
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Completed
      • The University of Oklahoma Health Sciences Center
  • Texas
    • San Antonio, Texas, United States, 78249-3539
      • Recruiting
      • Road Runner Research Ltd
  • Virginia
    • Norfolk, Virginia, United States, 23510-1021
      • Recruiting
      • Children's Specialty Group
  • Washington
    • Tacoma, Washington, United States, 98405-4048
      • Completed
      • Mary Bridge Children's Hospital - PIN
  • West Virginia
    • Huntington, West Virginia, United States, 25701-3656
      • Recruiting
      • Marshall University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eptinezumab 300 mg; Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).	Drug: Eptinezumab; Eptinezumab will be administered per dose and schedule specified in the arm.; Other Names: Vyepti
Experimental: Eptinezumab 100 mg; Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).	Drug: Eptinezumab; Eptinezumab will be administered per dose and schedule specified in the arm.; Other Names: Vyepti
Placebo Comparator: Placebo; Participants will receive a single IV infusion of placebo matching to eptinezumab.	Drug: Placebo; Placebo matching to eptinezumab will be administered per schedule specified in the arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12	Baseline, Weeks 1-12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12	Baseline, Weeks 1-12
Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12	Baseline, Weeks 1-12
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
Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4	Baseline up to Weeks 1-4
Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12	Baseline, Weeks 1-12
Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12	Baseline, Weeks 1-12
Free Eptinezumab Plasma Concentration	Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20)
Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])	From randomization (Week 0) up to Week 20
Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)	From randomization (Week 0) up to Week 20

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; eptinezumab
• Other Study ID Numbers: 19356A; 2020-001009-22 (EudraCT Number); 2024-510656-13-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No