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

June 11, 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
        • Expertia S.A- Mautalén Salud e Investigación
      • Córdoba, Argentina, X5000BNB
        • Recruiting
        • Hospital de Niños de La Santisima Trinidad
    • Buenos Aires
      • Munro, Buenos Aires, Argentina, 1605
        • Completed
        • Clínica Privada Independencia
    • Ciudad Autónoma de BuenosAires
      • Barracas, Ciudad Autónoma de BuenosAires, Argentina, C1280AEB
        • Completed
        • Hospital Britanico de Buenos Aires
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Recruiting
        • Instituto Médico Río 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
    • 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
    • Lazio
      • Rome, Lazio, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù IRCCS
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Recruiting
        • Istituto G Gaslini Ospedale Pediatrico IRCCS
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
      • 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)
      • Pisa, Tuscany, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
  • Mexico
      • Tepetlacolco, Mexico, 54055
        • Recruiting
        • Clinical Research Institute SC-Mexico
    • 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
      • Braga, Portugal, 4710-243
        • Recruiting
        • Centro Clínico Académico, Braga - Hospital de Braga
      • Coimbra, Portugal, 3000-602
        • Recruiting
        • ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
      • Lisbon, Portugal, 1998-018
        • Completed
        • Hospital CUF Descobertas
    • Porto District
      • Porto Covo, Porto District, Portugal, 4200-319
        • Recruiting
        • ULS de São João, EPE - Hospital de São João
    • Setúbal District
      • Porto Covo, Setúbal District, Portugal, 4050-651
        • Recruiting
        • ULS de Santo António, EPE - Centro Materno Infantil Norte
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Childrens University Hospital
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
      • Niš, Serbia, 18 000
        • Recruiting
        • University Clinical Center Nis
      • Novi Sad, Serbia, 21 000
        • Recruiting
        • Children and Youth Health Care Institute of Vojvodina
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinical Centre of Vojvodina
  • Spain
      • Barcelona, Spain, 8025
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • 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 Universitesi Istanbul Tip Fakultesi Hastanesi
      • Mersin, Turkey (Türkiye), 33169
        • Recruiting
        • Mersin Universitesi Tip Fakultesi Hastanesi
    • İzmir
      • Bayraklı, İzmir, Turkey (Türkiye), 35540
        • Recruiting
        • Izmir City Hospital
  • United Kingdom
      • Glasgow, United Kingdom, G514TF
        • Recruiting
        • Royal Hospital for Children (Glasgow) - PPDS - PIN
      • London, United Kingdom, WCIN 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children
    • 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
      • Stamford, Connecticut, United States, 06905-1206
        • Recruiting
        • Ki Health Partners LLC DBA New England Institute for Clinical Research
    • Florida
      • Gulf Breeze, Florida, United States, 32561-4495
        • Recruiting
        • Child Neurology of NW Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • AGA Clinical Trials - Hialeah - 4980 W 10th Ave
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida - 13330 USF Laurel Dr
    • Georgia
      • Atlanta, Georgia, United States, 30328-6191
        • Recruiting
        • Clinical Integrative Research Center of Atlanta
    • Kentucky
      • Lexington, Kentucky, United States, 40508-1683
        • Completed
        • University of Kentucky HealthCare (UKHC) Kentucky Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21201-1544
        • Recruiting
        • University of Maryland School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Completed
        • Michigan Head Pain and Neurological Institute
    • New York
      • 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
      • Akron, Ohio, United States, 44308-1063
        • Recruiting
        • Childrens Hospital Medical Center of Akron
      • Cincinnati, Ohio, United States, 45229-3026
        • Recruiting
        • Cincinnati Children's Hospital Medical Center - PIN
    • Texas
      • San Antonio, Texas, United States, 78249-3539
        • Recruiting
        • Road Runner Research Ltd
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Recruiting
        • Children's Specialty Group - 3 Commercial Place
    • Wisconsin
      • New Berlin, Wisconsin, United States, 53151-7494
        • Recruiting
        • Childrens Hospital of Wisconsin - PIN

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)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 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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