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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001009-22 | EudraCT Number | ||
| 2024-510656-13-00 | EU Trial (CTIS) Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab 300 mg | Experimental | Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted). |
|
| Eptinezumab 100 mg | Experimental | Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted). |
|
| Placebo | Placebo Comparator | Participants will receive a single IV infusion of placebo matching to eptinezumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | Eptinezumab will be administered per dose and schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 | Baseline, Weeks 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 | Baseline up to Weeks 1-12 | |
| Percentage of Participants With Migraine on the Day After Dosing (Day 1) | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | Contact | +45 36301311 | HQ_Medinfo@Lundbeck.com |
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Children's Hospital - PIN | Recruiting | New Haven | Connecticut | 06504-8901 | United States | |
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| Placebo | Drug | Placebo matching to eptinezumab will be administered per schedule specified in the arm. |
|
| Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12 | Baseline, Weeks 1-12 |
| Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 | Baseline up to Weeks 1-12 |
| Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 | Baseline up to Weeks 1-4 |
| Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 | Baseline up to Weeks 1-4 |
| Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 | Baseline, Weeks 1-12 |
| Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 | Baseline, Weeks 1-12 |
| Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12 | Baseline, Weeks 1-12 |
| Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12 | Baseline, Weeks 1-12 |
| Free Eptinezumab Plasma Concentration | 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]) | From randomization (Week 0) up to Week 20 |
| Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) | From randomization (Week 0) up to Week 20 |
| Ki Health Partners LLC DBA New England Institute for Clinical Research |
| Recruiting |
| Stamford |
| Connecticut |
| 06905-1206 |
| United States |
| Children's National Medical Center | Completed | Washington D.C. | District of Columbia | 20010-2916 | United States |
| NW FL Clinical Research Group, LLC | Recruiting | Gulf Breeze | Florida | 32561-4458 | United States |
| AGA Clinical Trials - Hialeah - 4980 W 10th Ave | Recruiting | Hialeah | Florida | 33012 | United States |
| Axcess Medical Research | Completed | Loxahatchee Groves | Florida | 33470-9272 | United States |
| University of South Florida | Recruiting | Tampa | Florida | 33612-6601 | United States |
| Clinical Integrative Research Center of Atlanta | Recruiting | Atlanta | Georgia | 30328-6191 | United States |
| University of Kentucky HealthCare (UKHC) Kentucky Clinic | Recruiting | Lexington | Kentucky | 40508-1683 | United States |
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
| Michigan Head Pain and Neurological Institute | Completed | Ann Arbor | Michigan | 48104-5131 | United States |
| Michigan State University - Department of Neurology | Completed | East Lansing | Michigan | 48824-7015 | United States |
| Corewell Health Butterworth Hospital | Completed | Grand Rapids | Michigan | 49503-2560 | United States |
| Dent Neurosciences Research Center Incorporated | Completed | Amherst | New York | 14226-1746 | United States |
| North Suffolk Neurology-Commack | Recruiting | Commack | New York | 11725-2808 | United States |
| OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte | Completed | Charlotte | North Carolina | 28211-5027 | United States |
| Cincinnati Children's Hospital Medical Center - PIN | Recruiting | Cincinnati | Ohio | 45229-3026 | United States |
| The University of Oklahoma Health Sciences Center | Completed | Oklahoma City | Oklahoma | 73104 | United States |
| Road Runner Research Ltd | Recruiting | San Antonio | Texas | 78249-3539 | United States |
| Children's Specialty Group | Recruiting | Norfolk | Virginia | 23510-1021 | United States |
| Mary Bridge Children's Hospital - PIN | Completed | Tacoma | Washington | 98405-4048 | United States |
| Marshall University Medical Center | Recruiting | Huntington | West Virginia | 25701-3656 | United States |
| Hospital Privado de La Comunidad | Completed | Mar del Plata | Buenos Aires | 7603 | Argentina |
| Clínica Privada Independencia | Completed | Munro | Buenos Aires | 1605 | Argentina |
| Hospital Italiano de Buenos Aires | Completed | Ciudad Autónoma Buenos Aires | Buenos Aires F.D. | C1181ACH | Argentina |
| Hospital Britanico de Buenos Aires | Completed | Buenos Aires | Ciudad Autónoma de BuenosAires | C1280 | Argentina |
| Sanatorio Allende S.A | Completed | Córdoba | Córdoba Province | X5000JHGQ | Argentina |
| Hospital de Niños de La Santisima Trinidad | Recruiting | Córdoba-Barrio Crisol | Córdoba Province | X5014AKM | Argentina |
| Instituto Médico Río Cuarto | Recruiting | Río Cuarto | Córdoba Province | 5800 | Argentina |
| INECO Neurociencias Oroño | Recruiting | Rosario | Santa Fe Province | S2000DTP | Argentina |
| Centro de Investigaciones Médicas Tucumán - PPDS | Recruiting | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Expertia S.A- Mautalén Salud e Investigación | Completed | Buenos Aires | C1128AAF | Argentina |
| University of Alberta | Completed | Edmonton | Alberta | T6G 2R7 | Canada |
| Medical Arts Health Research Group - Penticton - PPDS | Completed | Penticton | British Columbia | V2A 5L5 | Canada |
| Vancouver Island Health Authority | Recruiting | Victoria | British Columbia | V8R 1J8 | Canada |
| The Kids Clinic | Recruiting | Ajax | Ontario | L1Z 0M1 | Canada |
| London Health Sciences Centre -800 Commissioners Rd E | Recruiting | London | Ontario | N6A 5W9 | Canada |
| Azienda Ospedaliero Universitaria Consorziale Policlinico | Completed | Bari | Apulia | 70124 | Italy |
| Ospedale Pediatrico Bambino Gesù IRCCS | Recruiting | Rome | Lazio | 00165 | Italy |
| IRCCS Istituto Giannina Gaslini | Recruiting | Genoa | Liguria | 16147 | Italy |
| Ospedale San Raffaele S.r.l. | Recruiting | Milan | Lombardy | 20132 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Completed | Milan | Lombardy | 20133 | Italy |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS | Recruiting | Pavia | Lombardy | 27100 | Italy |
| AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza | Recruiting | Cagliari | Sardinia | 09121 | Italy |
| Azienda Ospedaliero Universitaria A Meyer (Duplicate) | Recruiting | Florence | Tuscany | 50139 | Italy |
| Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C. | Recruiting | Guadalajara | Jalisco | 44700 | Mexico |
| Unidad de Investigación en Salud de Chihuahua S.C. | Completed | Zapopan | Jalisco | 45150 | Mexico |
| Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia | Recruiting | Morelia | Michoacán | 58260 | Mexico |
| Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city | Completed | México | State of Mexico | 14050 | Mexico |
| ICARO Investigaciones en Medicina, S.A de C.V | Recruiting | Chihuahua City | 31000 | Mexico |
| Neurociencias Estudios Clinicos S.C. | Completed | Culiacán Sinaloa | 80020 | Mexico |
| Instituto de Investigationes Clinicas para la Salud A.C. | Recruiting | Durango | 34000 | Mexico |
| Clinical Research Institute SC-Mexico | Recruiting | Tepetlacolco | 54055 | Mexico |
| Centro de Estudios Clinicos Y Especialidades Medicas SC | Completed | Vista Hermosa | 64620 | Mexico |
| AthleticoMed | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-752 | Poland |
| Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa | Recruiting | Krakow | Lesser Poland Voivodeship | 30-363 | Poland |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. | Recruiting | Oświęcim | Lesser Poland Voivodeship | 32-600 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak | Recruiting | Wroclaw | Lower Silesian Voivodeship | 52-210 | Poland |
| ETG Lublin - PPDS | Recruiting | Lublin | Lublin Voivodeship | 20-412 | Poland |
| MTZ Clinical Research Powered by PRATIA - PPDS | Recruiting | Warsaw | Masovian Voivodeship | 02-172 | Poland |
| ETG Neuroscience - PPDS | Recruiting | Warsaw | Masovian Voivodeship | 02-677 | Poland |
| ULS de Almada-Seixal, EPE - Hospital Garcia de Orta | Recruiting | Almada | Setúbal District | 2805-267 | Portugal |
| ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra | Recruiting | Coimbra | 3000-602 | Portugal |
| ULS de São João, EPE - Hospital de São João | Recruiting | Porto | 4200-319 | Portugal |
| Childrens University Hospital | Recruiting | Belgrade | 11000 | Serbia |
| University Clinical Center Kragujevac | Recruiting | Kragujevac | 34000 | Serbia |
| Children and Youth Health Care Institute of Vojvodina | Recruiting | Novi Sad | 21 000 | Serbia |
| Clinical Centre of Vojvodina | Recruiting | Novi Sad | 21 000 | Serbia |
| CHUVI - H.U. Alvaro Cunqueiro | Recruiting | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Recruiting | Barcelona | 8025 | Spain |
| Instituto del Sueño | Completed | Madrid | 28036 | Spain |
| Hospital Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Recruiting | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Recruiting | Valencia | 46026 | Spain |
| Izmir City Hospital | Recruiting | Bayraklı | İzmir | 35540 | Turkey (Türkiye) |
| Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi | Recruiting | Eskişehir | 26480 | Turkey (Türkiye) |
| Istanbul Üniversitesi, Istanbul Tip Fakültesi, Nör | Recruiting | Fatih/Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty Hospital | Completed | Fatih/Istanbul | 34096 | Turkey (Türkiye) |
| Mersin University Medical Faculty | Recruiting | Mersin | 33169 | Turkey (Türkiye) |
| Royal Devon and Exeter Hospital NHS Trust - PPDS | Completed | Exeter | Devon | EX2 5DW | United Kingdom |
| Great Ormond Street Hospital - PPDS | Recruiting | London | Greater London | WC1N 3JH | United Kingdom |
| Royal Hospital for Children and Young People - PIN | Recruiting | Edinburgh | Midlothian | EH16 4TJ | United Kingdom |
| James Paget University Hospitals NHS Foundation Trust | Recruiting | Great Yarmouth | Norfolk | NR31 6LA | United Kingdom |
| Queen Elizabeth University Hospital - PPDS | Recruiting | Glasgow | North Lanarkshire | G51 4TF | United Kingdom |
| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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