ClinicalTrials.gg
Sign In
RecruitingNCT04965675PROSPECT-2Updated Oct 16, 2026

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

A Phase 3 interventional study of Eptinezumab and Placebo in Chronic Migraine in Children, sponsored by H. Lundbeck A/S. Recruiting at 79 sites in 11 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 4 months later.
Updated Oct 16, 2026Site recruiting status changedPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
285
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Migraine in Children

Browse trials for

03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 285 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Browse H. Lundbeck A/S studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
285 participants (estimated)

Study arms

  • Experimental
    Eptinezumab 300 mg

    Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).

    Drug: Eptinezumab

  • Experimental
    Eptinezumab 100 mg

    Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

    Drug: Eptinezumab

  • Placebo comparator
    Placebo

    Participants will receive a single IV infusion of placebo matching to eptinezumab.

    Drug: Placebo

Interventions

  • DrugEptinezumab

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

    Also known as: Vyepti

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Weeks 1-12

Secondary outcomes

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

    Time frame: Baseline up to Weeks 1-12

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

    Time frame: Day 1

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

    Time frame: Baseline, Weeks 1-12

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

    Time frame: Baseline up to Weeks 1-12

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

    Time frame: Baseline up to Weeks 1-4

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

    Time frame: Baseline up to Weeks 1-4

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

    Time frame: Baseline, Weeks 1-12

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

    Time frame: Baseline, Weeks 1-12

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

    Time frame: Baseline, Weeks 1-12

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

    Time frame: Baseline, Weeks 1-12

  11. Free Eptinezumab Plasma Concentration

    Time frame: 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])

    Time frame: From randomization (Week 0) up to Week 20

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

    Time frame: From randomization (Week 0) up to Week 20

07

Study locations

44 of 79 sites recruiting
  • Yale-New Haven Children's Hospital
    New Haven, Connecticut 06504-8901, United States
    Completed

    Not enrolling at this site — choose another above.

  • New England Institute for Clinical Research (NEICR) - Stamford
    Stamford, Connecticut 06905-1206, United States
    Recruiting
  • Children's National Hospital - Children's National Heart Center
    Washington D.C., District of Columbia 20010-2916, United States
    Completed

    Not enrolling at this site — choose another above.

  • Sarkis Clinical Trials - Gainsville
    Gainesville, Florida 32607, United States
    Completed

    Not enrolling at this site — choose another above.

  • NW FL Clinical Research Group, LLC
    Gulf Breeze, Florida 32561-4495, United States
    Recruiting
  • AGA Clinical Trials
    Hialeah, Florida 33012-3407, United States
    Recruiting
  • Axcess Medical Research - Loxahatchee
    Loxahatchee Groves, Florida 33470-9206, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of South Florida (USF) - Tampa Campus
    Tampa, Florida 33620, United States
    Recruiting
  • Clinical Integrative Research Center of Atlanta (CIRCAtl)
    Atlanta, Georgia 30328-5574, United States
    Completed

    Not enrolling at this site — choose another above.

  • UK HealthCare-Kentucky Clinic
    Lexington, Kentucky 40536, United States
    Recruiting
  • University of Maryland-Marlene and Stewart Greenebaum Cancer Center
    Baltimore, Maryland 21201-1595, United States
    Completed

    Not enrolling at this site — choose another above.

  • Michigan Headache & Neurological Institute (MHNI)
    Ann Arbor, Michigan 48104-5131, United States
    Completed

    Not enrolling at this site — choose another above.

  • Corewell Health - Butterworth Hospital
    Grand Rapids, Michigan 49503-2560, United States
    Completed

    Not enrolling at this site — choose another above.

  • Dent Neurosciences Research Center
    Amherst, New York 14226-1727, United States
    Completed

    Not enrolling at this site — choose another above.

  • True North Neurology - Commack (North Suffolk Neurology)
    Commack, New York 11725-2850, United States
    Completed

    Not enrolling at this site — choose another above.

  • OnSite Clinical Solutions, LLC - Charlotte
    Charlotte, North Carolina 28210-0106, United States
    Completed

    Not enrolling at this site — choose another above.

  • Cincinnati Children's Hospital Medical Center-Burnet Campus
    Cincinnati, Ohio 45229-3026, United States
    Recruiting
  • University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center
    Oklahoma City, Oklahoma 73104-5418, United States
    Completed

    Not enrolling at this site — choose another above.

  • Road Runner Research (RRR)
    San Antonio, Texas 78249-3539, United States
    Recruiting
  • Children's Specialty Group (CSG)
    Norfolk, Virginia 23510-1021, United States
    Recruiting
  • MultiCare Mary Bridge Children's Hospital and Health Center
    Tacoma, Washington 98405-4234, United States
    Completed

    Not enrolling at this site — choose another above.

  • Marshall Health-Marshall University Medical Center
    Huntington, West Virginia 25701-3656, United States
    Recruiting
  • Hospital Privado de Comunidad (HPC)
    Mar del Plata, Buenos Aires B7602CBM, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • Mautalén Salud e Investigación
    Buenos Aires, Buenos Aires F.D. C1128AAF, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • Sanatorio Allende S.A.
    Córdoba, Cordoba, Argentina X5000JHQ, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • Hospital de Niños de la Santísima Trinidad
    Córdoba, Córdoba Province X5014AKM, Argentina
    Recruiting
  • Instituto Médico Río Cuarto
    Río Cuarto, Córdoba Province 5800, Argentina
    Recruiting
  • INECO Neurociencias Oroño
    Rosario, Santa Fe Province S2000DTP, Argentina
    Recruiting
  • Centro de Investigaciones Medicas Tucuman
    San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina
    Recruiting
  • Clinica Independencia
    Buenos Aires, 1605, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • Hospital Italiano de Buenos Aires (HIBA) - Centro de Esclerosis Multiple Buenos Aires (CEMBA)
    Buenos Aires, C1181ACH, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • Hospital Britanico de Buenos Aires (HOB)
    Buenos Aires, C1280AEB, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • University of Alberta Hospital (UAH)
    Edmonton, Alberta T6G 2B7, Canada
    Completed

    Not enrolling at this site — choose another above.

  • The Medical Arts Health Research Group - Penticton
    Penticton, British Columbia V2A 5C8, Canada
    Completed

    Not enrolling at this site — choose another above.

  • Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic
    Victoria, British Columbia V8R 1J8, Canada
    Recruiting
  • Kids Clinic
    Ajax, Ontario L1Z 0M1, Canada
    Recruiting
  • London Health Sciences Centre (LHSC)
    London, Ontario N6A 5W9, Canada
    Recruiting
  • L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...
    Cagliari, South Sardinia 09121, Italy
    Completed

    Not enrolling at this site — choose another above.

  • Istituto Giannina Gaslini IRCCS
    Genoa, 16147, Italy
    Recruiting
  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
    Milan, 20133, Italy
    Completed

    Not enrolling at this site — choose another above.

  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico
    Pavia, 27100, Italy
    Recruiting
  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico
    Pavia, 27100, Italy
    Completed

    Not enrolling at this site — choose another above.

  • Ospedale Pediatrico Bambino Gesu - Gianicolo
    Rome, 00165, Italy
    Recruiting
  • Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C)
    Durango, Durango 34000, Mexico
    Recruiting
  • Centro de Investigacion Medico Biologica y Terapia Avanzada S.C. (CIMBYTA)
    Guadalajara, Jalisco 44130, Mexico
    Recruiting
  • Unidad de Investigación en Salud de Chihuahua S.C.
    Zapopan, Jalisco 45150, Mexico
    Completed

    Not enrolling at this site — choose another above.

  • Centro de Investigacion Clinica de Morelia, S.C.
    Morelia, Michoacán 58070, Mexico
    Completed

    Not enrolling at this site — choose another above.

  • Centro de Estudios Clinicos y Especialidades Medicas SC
    Monterrey, New Leon 64620, Mexico
    Completed

    Not enrolling at this site — choose another above.

  • Neurociencias Estudios Clinicos S.C.
    Culiacán, Sinaloa 80050, Mexico
    Completed

    Not enrolling at this site — choose another above.

  • Unidad de Investigación en Salud de Chihuahua S.C.
    México, State of Mexico 14050, Mexico
    Completed

    Not enrolling at this site — choose another above.

  • ICARO Investigaciones en Medicina, S.A de C.V
    Chihuahua City, 31000, Mexico
    Recruiting
  • Clinical Research Institute SC-Mexico
    Tepetlacolco, 54055, Mexico
    Recruiting
  • Centrum Medyczne Plejady
    Krakow, Lesser Poland Voivodeship 30-363, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k
    Oświęcim, Lesser Poland Voivodeship 32-600, Poland
    Recruiting
  • ETG Lublin
    Lublin, Lublin Voivodeship 20-412, Poland
    Recruiting
  • MTZ Clinical Research Powered by PRATIA
    Warsaw, Masovian Voivodeship 02-172, Poland
    Recruiting
  • European Trial group network Sp. z o.o - Neuroscience
    Warsaw, Masovian Voivodeship 02-677, Poland
    Recruiting
  • European Trial group network Sp. z o.o - Neuroscience
    Warsaw, Masovian Voivodeship 02-677, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Unidade Local de Saude de Almada-Seixal E.P.E. (ULSAS)
    Almada, Setúbal District 2805-267, Portugal
    Recruiting
  • Hospital Pediátrico de Coimbra
    Coimbra, 3000-602, Portugal
    Recruiting
  • Centro Hospitalar Universitario de Sao Joao (CHUSJ)
    Porto, 4200-319, Portugal
    Recruiting
  • Univerzitetska Decija Klinika (UDK) (University Children's Hospital)
    Belgrade, Beograd 11000, Serbia
    Recruiting
  • University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic
    Novi Sad, Juznobacki Okrug 21000, Serbia
    Recruiting
  • Institute of Child and Youth Health Care of Vojvodina
    Novi Sad, Juznobacki Okrug 21101, Serbia
    Recruiting
  • Clinical Center Kragujevac
    Kragujevac, Sumadijski Okrug 34000, Serbia
    Recruiting
  • Hospital Universitario Virgen del Rocio (HUVR)
    Seville, Seville 41013, Spain
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
    Completed

    Not enrolling at this site — choose another above.

  • Hospital Clinico San Carlos
    Madrid, 28040, Spain
    Recruiting
  • Istanbul Universitesi - Cerrahpasa Tip Fakultesi (Cerrahpasa Medical Faculty)
    Fatih, Istanbul 34098, Turkey (Türkiye)
    Completed

    Not enrolling at this site — choose another above.

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)
    Eskişehir, 26480, Turkey (Türkiye)
    Recruiting
  • Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi
    Istanbul, 34093, Turkey (Türkiye)
    Recruiting
  • İzmir Şehir Hastanesi
    Izmir, 35540, Turkey (Türkiye)
    Recruiting
  • Mersin Universitesi-Tip Fakultesi
    Mersin, 33343, Turkey (Türkiye)
    Recruiting
  • Royal Devon and Exeter Hospital NHS Trust - PPDS
    Exeter, Devon EX2 5DW, United Kingdom
    Completed

    Not enrolling at this site — choose another above.

  • NHS Lothian - Royal Hospital for Children & Young People (RHCYP)
    Edinburgh, Eastern Scotland EH16 4TJ, United Kingdom
    Recruiting
  • James Paget University Hospitals NHS Foundation Trust
    Great Yarmouth, Norfolk NR31 6LA, United Kingdom
    Recruiting
  • NHS Greater Glasgow and Clyde-Glasgow Clinical Research Facility - Queen Elizabeth University Hos...
    Glasgow, South Western Scotland G51 4TF, United Kingdom
    Recruiting
  • Great Ormond Street Hospital for Children NHS Foundation Trust
    London, WC1N 3JH, United Kingdom
    Completed

    Not enrolling at this site — choose another above.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Mar 2027, 68 months after the start.

Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 68 months is above that.

Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion Sep 2026 → Mar 2027 and completion Oct 2026 → Mar 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2021
First posted
Jul 16, 2021
StartActual
Jun 30, 2021
Primary completionEst.
Mar 26, 2027was Sep 2026
CompletionEst.
Mar 26, 2027was Oct 2026
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
55 sites added, 59 sites removed. Great Ormond Street Hospital for Children NHS Foundation Trust is now Completed
Show 55 added (15 United States, 6 Poland, 5 Argentina, 5 Italy, 5 Turkey (Türkiye), 4 Mexico, 4 Serbia, 3 Canada, 3 Portugal, 3 Spain, 2 United Kingdom)
  • Yale-New Haven Children's Hospital · New Haven, United States
  • New England Institute for Clinical Research (NEICR) - Stamford · Stamford, United States
  • Children's National Hospital - Children's National Heart Center · Washington D.C., United States
  • Sarkis Clinical Trials - Gainsville · Gainesville, United States
  • AGA Clinical Trials · Hialeah, United States
  • University of South Florida (USF) - Tampa Campus · Tampa, United States
  • UK HealthCare-Kentucky Clinic · Lexington, United States
  • Michigan Headache & Neurological Institute (MHNI) · Ann Arbor, United States
  • Dent Neurosciences Research Center · Amherst, United States
  • True North Neurology - Commack (North Suffolk Neurology) · Commack, United States
  • OnSite Clinical Solutions, LLC - Charlotte · Charlotte, United States
  • Cincinnati Children's Hospital Medical Center-Burnet Campus · Cincinnati, United States
  • University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center · Oklahoma City, United States
  • Road Runner Research (RRR) · San Antonio, United States
  • MultiCare Mary Bridge Children's Hospital and Health Center · Tacoma, United States
  • Hospital Privado de Comunidad (HPC) · Mar del Plata, Argentina
  • Mautalén Salud e Investigación · Buenos Aires, Argentina
  • Hospital de Niños de la Santísima Trinidad · Córdoba, Argentina
  • Centro de Investigaciones Medicas Tucuman · San Miguel de Tucumán, Argentina
  • Clinica Independencia · Buenos Aires, Argentina
  • The Medical Arts Health Research Group - Penticton · Penticton, Canada
  • Kids Clinic · Ajax, Canada
  • London Health Sciences Centre (LHSC) · London, Canada
  • L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret... · Cagliari, Italy
  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan, Italy
  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico · Pavia, Italy
  • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico · Pavia, Italy
  • Ospedale Pediatrico Bambino Gesu - Gianicolo · Rome, Italy
  • Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C) · Durango, Mexico
  • Centro de Investigacion Clinica de Morelia, S.C. · Morelia, Mexico
  • …and 25 more on the registry record
Show 59 removed
  • Yale-New Haven Children's Hospital - PIN · New Haven, United States
  • Ki Health Partners LLC DBA New England Institute for Clinical Research · Stamford, United States
  • Children's National Medical Center · Washington D.C., United States
  • Sarkis Clinical Trials - Gainesville · Gainesville, United States
  • AGA Clinical Trials - Hialeah - 4980 W 10th Ave · Hialeah, United States
  • University of South Florida - 13330 USF Laurel Dr · Tampa, United States
  • University of Kentucky HealthCare (UKHC) Kentucky Clinic · Lexington, United States
  • Michigan Head Pain and Neurological Institute · Ann Arbor, United States
  • Dent Neurosciences Research Center Incorporated · Amherst, United States
  • North Suffolk Neurology-Commack · Commack, United States
  • OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte · Charlotte, United States
  • Cincinnati Children's Hospital Medical Center - PIN · Cincinnati, United States
  • The University of Oklahoma Health Sciences Center · Oklahoma City, United States
  • Road Runner Research Ltd · San Antonio, United States
  • Mary Bridge Children's Hospital - PIN · Tacoma, United States
  • Hospital Privado de La Comunidad · Mar del Plata, Argentina
  • Clínica Privada Independencia · Munro, Argentina
  • Hospital de Niños de La Santisima Trinidad · Córdoba-Barrio Crisol, Argentina
  • Centro de Investigaciones Médicas Tucumán - PPDS · San Miguel de Tucumán, Argentina
  • Expertia S.A- Mautalén Salud e Investigación · Buenos Aires, Argentina
  • Medical Arts Health Research Group - Penticton - PPDS · Penticton, Canada
  • The Kids Clinic · Ajax, Canada
  • London Health Sciences Centre -800 Commissioners Rd E · London, Canada
  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS · Pavia, Italy
  • IRCCS Ospedale Pediatrico Bambino Gesu · Rome, Italy
  • Fondazione IRCCS Istituto Neurologico Carlo Besta · Milan, Italy
  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS · Pavia, Italy
  • AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza · Cagliari, Italy
  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS · Pavia, Italy
  • Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia · Morelia, Mexico
  • …and 29 more on the registry record
Oct 16, 2026
Primary completion
Sep 5, 2026→Mar 26, 2027
Oct 16, 2026
Study completion
Oct 31, 2026→Mar 26, 2027
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    55 sites added, 59 sites removed. Great Ormond Street Hospital for Children NHS Foundation Trust is now Completed
    Show 55 added (15 United States, 6 Poland, 5 Argentina, 5 Italy, 5 Turkey (Türkiye), 4 Mexico, 4 Serbia, 3 Canada, 3 Portugal, 3 Spain, 2 United Kingdom)
    • Yale-New Haven Children's Hospital · New Haven, United States
    • New England Institute for Clinical Research (NEICR) - Stamford · Stamford, United States
    • Children's National Hospital - Children's National Heart Center · Washington D.C., United States
    • Sarkis Clinical Trials - Gainsville · Gainesville, United States
    • AGA Clinical Trials · Hialeah, United States
    • University of South Florida (USF) - Tampa Campus · Tampa, United States
    • UK HealthCare-Kentucky Clinic · Lexington, United States
    • Michigan Headache & Neurological Institute (MHNI) · Ann Arbor, United States
    • Dent Neurosciences Research Center · Amherst, United States
    • True North Neurology - Commack (North Suffolk Neurology) · Commack, United States
    • OnSite Clinical Solutions, LLC - Charlotte · Charlotte, United States
    • Cincinnati Children's Hospital Medical Center-Burnet Campus · Cincinnati, United States
    • University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer Center · Oklahoma City, United States
    • Road Runner Research (RRR) · San Antonio, United States
    • MultiCare Mary Bridge Children's Hospital and Health Center · Tacoma, United States
    • Hospital Privado de Comunidad (HPC) · Mar del Plata, Argentina
    • Mautalén Salud e Investigación · Buenos Aires, Argentina
    • Hospital de Niños de la Santísima Trinidad · Córdoba, Argentina
    • Centro de Investigaciones Medicas Tucuman · San Miguel de Tucumán, Argentina
    • Clinica Independencia · Buenos Aires, Argentina
    • The Medical Arts Health Research Group - Penticton · Penticton, Canada
    • Kids Clinic · Ajax, Canada
    • London Health Sciences Centre (LHSC) · London, Canada
    • L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret... · Cagliari, Italy
    • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan, Italy
    • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico · Pavia, Italy
    • Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico · Pavia, Italy
    • Ospedale Pediatrico Bambino Gesu - Gianicolo · Rome, Italy
    • Instituto de Investigaciones Clinicas para la Salud A.C. (IICS A.C) · Durango, Mexico
    • Centro de Investigacion Clinica de Morelia, S.C. · Morelia, Mexico
    • …and 25 more on the registry record
    Show 59 removed
    • Yale-New Haven Children's Hospital - PIN · New Haven, United States
    • Ki Health Partners LLC DBA New England Institute for Clinical Research · Stamford, United States
    • Children's National Medical Center · Washington D.C., United States
    • Sarkis Clinical Trials - Gainesville · Gainesville, United States
    • AGA Clinical Trials - Hialeah - 4980 W 10th Ave · Hialeah, United States
    • University of South Florida - 13330 USF Laurel Dr · Tampa, United States
    • University of Kentucky HealthCare (UKHC) Kentucky Clinic · Lexington, United States
    • Michigan Head Pain and Neurological Institute · Ann Arbor, United States
    • Dent Neurosciences Research Center Incorporated · Amherst, United States
    • North Suffolk Neurology-Commack · Commack, United States
    • OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte · Charlotte, United States
    • Cincinnati Children's Hospital Medical Center - PIN · Cincinnati, United States
    • The University of Oklahoma Health Sciences Center · Oklahoma City, United States
    • Road Runner Research Ltd · San Antonio, United States
    • Mary Bridge Children's Hospital - PIN · Tacoma, United States
    • Hospital Privado de La Comunidad · Mar del Plata, Argentina
    • Clínica Privada Independencia · Munro, Argentina
    • Hospital de Niños de La Santisima Trinidad · Córdoba-Barrio Crisol, Argentina
    • Centro de Investigaciones Médicas Tucumán - PPDS · San Miguel de Tucumán, Argentina
    • Expertia S.A- Mautalén Salud e Investigación · Buenos Aires, Argentina
    • Medical Arts Health Research Group - Penticton - PPDS · Penticton, Canada
    • The Kids Clinic · Ajax, Canada
    • London Health Sciences Centre -800 Commissioners Rd E · London, Canada
    • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS · Pavia, Italy
    • IRCCS Ospedale Pediatrico Bambino Gesu · Rome, Italy
    • Fondazione IRCCS Istituto Neurologico Carlo Besta · Milan, Italy
    • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS · Pavia, Italy
    • AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza · Cagliari, Italy
    • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS · Pavia, Italy
    • Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia · Morelia, Mexico
    • …and 29 more on the registry record
    Primary completion Sep 5, 2026→Mar 26, 2027
    Study completion Oct 31, 2026→Mar 26, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04965675
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Jul 16, 2021
Start date
Jun 30, 2021
Primary completion
Mar 26, 2027 (estimated)
Completion
Mar 26, 2027 (estimated)
Last update
Oct 16, 2026

Study contacts

Email contact via H. Lundbeck A/S
Contact
HQ_Medinfo@Lundbeck.com
+45 36301311
Email contact via H. Lundbeck A/S
study director · H. Lundbeck A/S

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Eptinezumab

Other studies in this condition

Migraine Disorders →

Other studies from this sponsor

H. Lundbeck A/S →

Start the discussion