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Chronic Migraine in ChildrenPhase 3PROSPECT-2NCT04965675

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

A Phase 3 study testing Eptinezumab in people with Chronic Migraine in Children, run by H. Lundbeck A/S at 79 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Chronic Migraine in Children
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
79 sitesin 11 countries
Study dates
30 Jun 2021to 26 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

79 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Email contact via H. Lundbeck A/S contact

+45 36301311

HQ_Medinfo@Lundbeck.com

79 sites in 11 countries

United States22 sites, 9 recruiting

  • Dent Neurosciences Research Center

    Amherst, New York, 14226-1727

    Completed

  • Michigan Headache & Neurological Institute (MHNI)

    Ann Arbor, Michigan, 48104-5131

    Completed

  • Clinical Integrative Research Center of Atlanta (CIRCAtl)

    Atlanta, Georgia, 30328-5574

    Completed

  • University of Maryland-Marlene and Stewart Greenebaum Cancer Center

    Baltimore, Maryland, 21201-1595

    Completed

  • OnSite Clinical Solutions, LLC - Charlotte

    Charlotte, North Carolina, 28210-0106

    Completed

  • Cincinnati Children's Hospital Medical Center-Burnet Campus

    Cincinnati, Ohio, 45229-3026

    Recruiting

  • True North Neurology - Commack (North Suffolk Neurology)

    Commack, New York, 11725-2850

    Completed

  • Sarkis Clinical Trials - Gainsville

    Gainesville, Florida, 32607

    Completed

  • Corewell Health - Butterworth Hospital

    Grand Rapids, Michigan, 49503-2560

    Completed

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561-4495

    Recruiting

  • AGA Clinical Trials

    Hialeah, Florida, 33012-3407

    Recruiting

  • Marshall Health-Marshall University Medical Center

    Huntington, West Virginia, 25701-3656

    Recruiting

  • UK HealthCare-Kentucky Clinic

    Lexington, Kentucky, 40536

    Recruiting

  • Axcess Medical Research - Loxahatchee

    Loxahatchee Groves, Florida, 33470-9206

    Completed

  • Yale-New Haven Children's Hospital

    New Haven, Connecticut, 06504-8901

    Completed

  • Children's Specialty Group (CSG)

    Norfolk, Virginia, 23510-1021

    Recruiting

  • University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center

    Oklahoma City, Oklahoma, 73104-5418

    Completed

  • Road Runner Research (RRR)

    San Antonio, Texas, 78249-3539

    Recruiting

  • New England Institute for Clinical Research (NEICR) - Stamford

    Stamford, Connecticut, 06905-1206

    Recruiting

  • MultiCare Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98405-4234

    Completed

  • University of South Florida (USF) - Tampa Campus

    Tampa, Florida, 33620

    Recruiting

  • Children's National Hospital - Children's National Heart Center

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

    Completed

Other trials in United States

Argentina10 sites, 4 recruiting

  • Mautalén Salud e Investigación

    Buenos Aires, Buenos Aires F.D., C1128AAF

    Completed

  • Clinica Independencia

    Buenos Aires, 1605

    Completed

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

    Buenos Aires, C1181ACH

    Completed

  • Hospital Britanico de Buenos Aires (HOB)

    Buenos Aires, C1280AEB

    Completed

  • Sanatorio Allende S.A.

    Córdoba, Cordoba, Argentina, X5000JHQ

    Completed

  • Hospital de Niños de la Santísima Trinidad

    Córdoba, Córdoba Province, X5014AKM

    Recruiting

  • Hospital Privado de Comunidad (HPC)

    Mar del Plata, Buenos Aires, B7602CBM

    Completed

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, 5800

    Recruiting

  • INECO Neurociencias Oroño

    Rosario, Santa Fe Province, S2000DTP

    Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL

    Recruiting

Other trials in Argentina

Mexico9 sites, 4 recruiting

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

    Chihuahua City, 31000

    Recruiting

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80050

    Completed

  • Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C)

    Durango, Durango, 34000

    Recruiting

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

    Guadalajara, Jalisco, 44130

    Recruiting

  • Unidad de Investigación en Salud de Chihuahua S.C.

    México, State of Mexico, 14050

    Completed

  • Centro de Estudios Clinicos y Especialidades Medicas SC

    Monterrey, New Leon, 64620

    Completed

  • Centro de Investigacion Clinica de Morelia, S.C.

    Morelia, Michoacán, 58070

    Completed

  • Clinical Research Institute SC-Mexico

    Tepetlacolco, 54055

    Recruiting

  • Unidad de Investigación en Salud de Chihuahua S.C.

    Zapopan, Jalisco, 45150

    Completed

Other trials in Mexico

Italy6 sites, 3 recruiting

  • L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...

    Cagliari, South Sardinia, 09121

    Completed

  • Istituto Giannina Gaslini IRCCS

    Genoa, 16147

    Recruiting

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    Milan, 20133

    Completed

  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

    Pavia, 27100

    Recruiting

  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico

    Pavia, 27100

    Completed

  • Ospedale Pediatrico Bambino Gesu - Gianicolo

    Rome, 00165

    Recruiting

Other trials in Italy

Poland6 sites, 4 recruiting

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, 30-363

    Completed

  • ETG Lublin

    Lublin, Lublin Voivodeship, 20-412

    Recruiting

  • Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k

    Oświęcim, Lesser Poland Voivodeship, 32-600

    Recruiting

  • MTZ Clinical Research Powered by PRATIA

    Warsaw, Masovian Voivodeship, 02-172

    Recruiting

  • European Trial group network Sp. z o.o - Neuroscience

    Warsaw, Masovian Voivodeship, 02-677

    Recruiting

  • European Trial group network Sp. z o.o - Neuroscience

    Warsaw, Masovian Voivodeship, 02-677

    Completed

Other trials in Poland

Canada5 sites, 3 recruiting

  • Kids Clinic

    Ajax, Ontario, L1Z 0M1

    Recruiting

  • University of Alberta Hospital (UAH)

    Edmonton, Alberta, T6G 2B7

    Completed

  • London Health Sciences Centre (LHSC)

    London, Ontario, N6A 5W9

    Recruiting

  • The Medical Arts Health Research Group - Penticton

    Penticton, British Columbia, V2A 5C8

    Completed

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

    Victoria, British Columbia, V8R 1J8

    Recruiting

Other trials in Canada

Turkey (Türkiye)5 sites, 4 recruiting

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)

    Eskişehir, 26480

    Recruiting

  • Istanbul Universitesi - Cerrahpasa Tip Fakultesi (Cerrahpasa Medical Faculty)

    Fatih, Istanbul, 34098

    Completed

  • Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi

    Istanbul, 34093

    Recruiting

  • İzmir Şehir Hastanesi

    Izmir, 35540

    Recruiting

  • Mersin Universitesi-Tip Fakultesi

    Mersin, 33343

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom5 sites, 3 recruiting

  • NHS Lothian - Royal Hospital for Children & Young People (RHCYP)

    Edinburgh, Eastern Scotland, EH16 4TJ

    Recruiting

  • Royal Devon and Exeter Hospital NHS Trust - PPDS

    Exeter, Devon, EX2 5DW

    Completed

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

    Glasgow, South Western Scotland, G51 4TF

    Recruiting

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk, NR31 6LA

    Recruiting

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London, WC1N 3JH

    Completed

Other trials in United Kingdom

Serbia4 sites, 4 recruiting

  • Univerzitetska Decija Klinika (UDK) (University Children's Hospital)

    Belgrade, Beograd, 11000

    Recruiting

  • Clinical Center Kragujevac

    Kragujevac, Sumadijski Okrug, 34000

    Recruiting

  • University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic

    Novi Sad, Juznobacki Okrug, 21000

    Recruiting

  • Institute of Child and Youth Health Care of Vojvodina

    Novi Sad, Juznobacki Okrug, 21101

    Recruiting

Other trials in Serbia

Spain4 sites, 3 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Completed

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario Virgen del Rocio (HUVR)

    Seville, Seville, 41013

    Recruiting

Other trials in Spain

Portugal3 sites, 3 recruiting

  • Unidade Local de Saude de Almada-Seixal E.P.E. (ULSAS)

    Almada, Setúbal District, 2805-267

    Recruiting

  • Hospital Pediátrico de Coimbra

    Coimbra, 3000-602

    Recruiting

  • Centro Hospitalar Universitario de Sao Joao (CHUSJ)

    Porto, 4200-319

    Recruiting

Other trials in Portugal

About this study

Official title: 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.

Read the 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.

Being tested
Eptinezumab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EptinezumabDrug

    Also called Vyepti

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

  • PlaceboDrug

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

Study groups in NCT04965675
Study groupRoleWhat they receive
Eptinezumab 300 mgExperimentalParticipants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).
Receives: Drug: Eptinezumab
Eptinezumab 100 mgExperimentalParticipants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Receives: Drug: Eptinezumab
PlaceboPlacebo comparatorParticipants will receive a single IV infusion of placebo matching to eptinezumab.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, Weeks 1-12

Secondary outcomes (13)

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

    Measured: Baseline up to Weeks 1-12

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

    Measured: Day 1

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

    Measured: Baseline, Weeks 1-12

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

    Measured: Baseline up to Weeks 1-12

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

    Measured: Baseline up to Weeks 1-4

  6. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4

    Measured: Baseline up to Weeks 1-4

  7. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12

    Measured: Baseline, Weeks 1-12

  8. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12

    Measured: Baseline, Weeks 1-12

  9. Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12

    Measured: Baseline, Weeks 1-12

  10. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12

    Measured: Baseline, Weeks 1-12

  11. Free Eptinezumab Plasma Concentration

    Measured: Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20)

  12. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])

    Measured: From randomization (Week 0) up to Week 20

  13. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)

    Measured: From randomization (Week 0) up to Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start30 Jun 2021
  3. Primary completion26 Mar 2027 (estimated)
  4. Study completion26 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
285 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965675
Sponsor's protocol ID
19356A
Other IDs
2020-001009-22, 2024-510656-13-00
Acronym
PROSPECT-2
Status last verified
Oct 2026
First submitted
7 Jul 2021
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eptinezumab in people with Chronic Migraine in Children, run by H. Lundbeck A/S at 79 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Argentina, Mexico, Italy, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Email contact via H. Lundbeck A/S (+45 36301311, HQ_Medinfo@Lundbeck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 (time frame: Baseline, Weeks 1-12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04965675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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