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.
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
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.
79 sites in 11 countries
United States22 sites, 9 recruiting
- Completed
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
- Recruiting
Cincinnati Children's Hospital Medical Center-Burnet Campus
Cincinnati, Ohio, 45229-3026
- Completed
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
- Recruiting
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
- Completed
Axcess Medical Research - Loxahatchee
Loxahatchee Groves, Florida, 33470-9206
- Completed
Yale-New Haven Children's Hospital
New Haven, Connecticut, 06504-8901
- Recruiting
Children's Specialty Group (CSG)
Norfolk, Virginia, 23510-1021
- Completed
University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, 73104-5418
- Recruiting
Road Runner Research (RRR)
San Antonio, Texas, 78249-3539
- Recruiting
New England Institute for Clinical Research (NEICR) - Stamford
Stamford, Connecticut, 06905-1206
- Completed
MultiCare Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405-4234
- Recruiting
University of South Florida (USF) - Tampa Campus
Tampa, Florida, 33620
- Completed
Children's National Hospital - Children's National Heart Center
Washington D.C., District of Columbia, 20010-2916
Argentina10 sites, 4 recruiting
- Completed
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
- Recruiting
Hospital de Niños de la Santísima Trinidad
Córdoba, Córdoba Province, X5014AKM
- Completed
Hospital Privado de Comunidad (HPC)
Mar del Plata, Buenos Aires, B7602CBM
- Recruiting
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
Mexico9 sites, 4 recruiting
- Recruiting
ICARO Investigaciones en Medicina, S.A de C.V
Chihuahua City, 31000
- Completed
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, 80050
- Recruiting
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
- Completed
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
- Recruiting
Clinical Research Institute SC-Mexico
Tepetlacolco, 54055
- Completed
Unidad de Investigación en Salud de Chihuahua S.C.
Zapopan, Jalisco, 45150
Italy6 sites, 3 recruiting
- Completed
L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...
Cagliari, South Sardinia, 09121
- Recruiting
Istituto Giannina Gaslini IRCCS
Genoa, 16147
- Completed
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, 20133
- Recruiting
Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico
Pavia, 27100
- Completed
Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico
Pavia, 27100
- Recruiting
Ospedale Pediatrico Bambino Gesu - Gianicolo
Rome, 00165
Poland6 sites, 4 recruiting
- Completed
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363
- Recruiting
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
- Completed
European Trial group network Sp. z o.o - Neuroscience
Warsaw, Masovian Voivodeship, 02-677
Canada5 sites, 3 recruiting
- Recruiting
Kids Clinic
Ajax, Ontario, L1Z 0M1
- Completed
University of Alberta Hospital (UAH)
Edmonton, Alberta, T6G 2B7
- Recruiting
London Health Sciences Centre (LHSC)
London, Ontario, N6A 5W9
- Completed
The Medical Arts Health Research Group - Penticton
Penticton, British Columbia, V2A 5C8
- Recruiting
Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic
Victoria, British Columbia, V8R 1J8
Turkey (Türkiye)5 sites, 4 recruiting
- Recruiting
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)
Eskişehir, 26480
- Completed
Istanbul Universitesi - Cerrahpasa Tip Fakultesi (Cerrahpasa Medical Faculty)
Fatih, Istanbul, 34098
- Recruiting
Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi
Istanbul, 34093
- Recruiting
İzmir Şehir Hastanesi
Izmir, 35540
- Recruiting
Mersin Universitesi-Tip Fakultesi
Mersin, 33343
United Kingdom5 sites, 3 recruiting
- Recruiting
NHS Lothian - Royal Hospital for Children & Young People (RHCYP)
Edinburgh, Eastern Scotland, EH16 4TJ
- Completed
Royal Devon and Exeter Hospital NHS Trust - PPDS
Exeter, Devon, EX2 5DW
- Recruiting
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
- Completed
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH
Serbia4 sites, 4 recruiting
- 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
Spain4 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Completed
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
- Recruiting
Hospital Universitario Virgen del Rocio (HUVR)
Seville, Seville, 41013
Portugal3 sites, 3 recruiting
- 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
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.
- Conditions
- Chronic Migraine in Children
- 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 group | Role | What they receive |
|---|---|---|
| Eptinezumab 300 mg | Experimental | Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted). Receives: Drug: Eptinezumab |
| Eptinezumab 100 mg | Experimental | Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted). Receives: Drug: Eptinezumab |
| Placebo | Placebo comparator | Participants 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.
Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Measured: Baseline, Weeks 1-12
Secondary outcomes (13)
Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
Measured: Baseline up to Weeks 1-12
Percentage of Participants With Migraine on the Day After Dosing (Day 1)
Measured: Day 1
Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
Measured: Baseline, Weeks 1-12
Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
Measured: Baseline up to Weeks 1-12
Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
Measured: Baseline up to Weeks 1-4
Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
Measured: Baseline up to Weeks 1-4
Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
Measured: Baseline, Weeks 1-12
Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
Measured: Baseline, Weeks 1-12
Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
Measured: Baseline, Weeks 1-12
Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12
Measured: Baseline, Weeks 1-12
Free Eptinezumab Plasma Concentration
Measured: 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])
Measured: From randomization (Week 0) up to Week 20
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.
- First posted16 Jul 2021
- Study start30 Jun 2021
- Primary completion26 Mar 2027 (estimated)
- Study completion26 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine in ChildrenStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
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