A Study of Eptinezumab in Pediatric Participants With Episodic Migraine (PROSPECT-1)

September 7, 2026 updated by: H. Lundbeck A/S

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

315

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1128AAF
        • Completed
        • Mautalen Salud e investigación
      • Buenos Aires, Argentina, C1280AEB
        • Completed
        • Hospital Britanico de Buenos Aires (HOB)
      • Buenos Aires, Argentina, 1605
        • Completed
        • Clinica Independencia
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5014AKM
        • Recruiting
        • Hospital de Niños de La Santisima 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 Tucuman
  • Canada
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 5C8
        • Completed
        • The Medical Arts Health Research Group - Penticton
      • Victoria, British Columbia, Canada, V8R 1J8
        • Recruiting
        • Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • Recruiting
        • Kids Clinic
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre (LHSC)
  • Italy
      • Genoa, Italy, 16147
        • Recruiting
        • Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare
      • Milan, Italy, 20133
        • Completed
        • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To...
      • Rome, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesu - Gianicolo
    • South Sardinia
      • Cagliari, South Sardinia, Italy, 09121
        • Recruiting
        • L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...
  • Mexico
      • Tepetlacolco, Mexico, 54055
        • Recruiting
        • Clinical Research Institute SC-Mexico
    • Michoacán
      • Morelia, Michoacán, Mexico, 58070
        • Completed
        • Centro de Investigacion Clinica de Morelia, S.C.
  • Poland
    • Kuyavian-Pomerania
      • Bydgoszcz, Kuyavian-Pomerania, Poland, 85-752
        • Recruiting
        • AthleticoMed Sp. z o.o.
    • 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
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-412
        • Recruiting
        • ETG Lublin
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by PRATIA
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • Recruiting
        • European Trial group network Sp. z o.o - Neuroscience
  • Portugal
      • Braga, Portugal, 4710-367
        • Recruiting
        • Hospital de Braga
      • Coimbra, Portugal, 3000-602
        • Recruiting
        • Hospital Pediátrico de Coimbra
      • Lisbon, Portugal, 1998-018
        • Completed
        • Hospital CUF Descobertas, S.A.
      • Porto, Portugal, 4050
        • Recruiting
        • Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)
      • Porto, Portugal, 4200-319
        • Recruiting
        • Centro Hospitalar Universitario de Sao Joao (CHUSJ)
  • Serbia
      • Niš, Serbia, 18 000
        • Recruiting
        • University Clinical Center Nis
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Recruiting
        • Univerzitetska Decija Klinika (UDK) (University Children's Hospital)
    • Juznobacki Okrug
      • Novi Sad, Juznobacki Okrug, Serbia, 21000
        • Recruiting
        • University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic
      • Novi Sad, Juznobacki Okrug, Serbia, 21101
        • Recruiting
        • Institute of Child and Youth Health Care of Vojvodina
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • Recruiting
        • Clinical Center Kragujevac
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC)
  • Turkey (Türkiye)
      • Eskişehir, Turkey (Türkiye), 26480
        • Recruiting
        • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)
      • Istanbul, Turkey (Türkiye), 34093
        • Recruiting
        • Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi
      • Izmir, Turkey (Türkiye), 35540
        • Recruiting
        • Izmir Şehir Hastanesi
      • Mersin, Turkey (Türkiye), 33343
        • Recruiting
        • Mersin Universitesi-Tip Fakultesi
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children NHS Foundation Trust
    • Eastern Scotland
      • Edinburgh, Eastern Scotland, United Kingdom, EH16 4TJ
        • Recruiting
        • NHS Lothian - Royal Hospital for Children & Young People (RHCYP)
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
        • Recruiting
        • James Paget University Hospitals NHS Foundation Trust
    • South Western Scotland
      • Glasgow, South Western Scotland, United Kingdom, G51 4TF
        • Recruiting
        • NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...
  • United States
    • Connecticut
      • Stamford, Connecticut, United States, 06905-1206
        • Recruiting
        • New England Institute for Clinical Research (NEICR) - Stamford
    • Florida
      • Gulf Breeze, Florida, United States, 32561-4458
        • Recruiting
        • Child Neurology Center (CNC) of Northwest Florida
      • Hialeah, Florida, United States, 33012-3407
        • Recruiting
        • AGA Clinical Trials
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida (USF) - Tampa Campus
    • Georgia
      • Atlanta, Georgia, United States, 30328-5574
        • Completed
        • Clinical Integrative Research Center of Atlanta (CIRCAtl)
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Completed
        • UK HealthCare-Kentucky Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21201-1509
        • Completed
        • University of Maryland School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Completed
        • Michigan Headache & Neurological Institute (MHNI)
    • New York
      • Commack, New York, United States, 11725-2850
        • Completed
        • True North Neurology - Commack (North Suffolk Neurology)
    • North Carolina
      • Charlotte, North Carolina, United States, 28210-0106
        • Completed
        • OnSite Clinical Solutions, LLC - Charlotte
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Recruiting
        • Akron Children's Hospital
      • Cincinnati, Ohio, United States, 45229-3026
        • Recruiting
        • Cincinnati Children's Hospital Medical Center-Burnet Campus
    • Texas
      • San Antonio, Texas, United States, 78249-3539
        • Recruiting
        • Road Runner Research (RRR)
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Specialty Group (CSG)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
  • During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
  • During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.

Exclusion Criteria:

  • History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min).
  • History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
  • Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
  • Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.

Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eptinezumab 100 mg
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Drug: Eptinezumab
Solution for infusion
Experimental: Eptinezumab 300 mg
Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
Drug: Eptinezumab
Solution for infusion
Placebo Comparator: Placebo
Participants will receive a single IV infusion of matching placebo to eptinezumab.
Drug: Placebo
Solution for infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Response: ≥50% Reduction From Baseline in MMDs
Time Frame: Baseline, Weeks 1-4 and Weeks 1-12
Baseline, Weeks 1-4 and Weeks 1-12
Percentage of Participants with Migraine on the Day After Dosing (Day 1)
Time Frame: On Day After Dosing
On Day After Dosing
Change From Baseline in MMDs with Acute Medication Use
Time Frame: Baseline, Weeks 1-12
Baseline, Weeks 1-12
Response: ≥75% reduction from baseline in MMDs
Time Frame: Baseline, Weeks 1-4 and Weeks 1-12
Baseline, Weeks 1-4 and Weeks 1-12
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Time Frame: Baseline, Weeks 1-12
Baseline, Weeks 1-12
Change From Baseline in Monthly Hours with Headache
Time Frame: Baseline, Weeks 1-12
Baseline, Weeks 1-12
Change From Baseline in Days with Acute Medication
Time Frame: Baseline, Weeks 1-12
Baseline, Weeks 1-12
Change From Baseline in Rate of Migraines with Severe Pain Intensity
Time Frame: Baseline, Weeks 1-12
Baseline, Weeks 1-12
Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score
Time Frame: Baseline, Week 12
Baseline, Week 12
Free Eptinezumab Plasma Concentrations
Time Frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Day 0 (pre-dose) and at Weeks 8, 12, and 20
Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Time Frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Day 0 (pre-dose) and at Weeks 8, 12, and 20
Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)
Time Frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Day 0 (pre-dose) and at Weeks 8, 12, and 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, HQ_Medinfo@Lundbeck.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Estimated)

July 6, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19357A
  • 2022-502538-14-00 (Other Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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