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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502917-27-00 | Other Identifier | EU CTR No. |
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The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.
This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine [CM] study in adolescents) or 19357A (episodic migraine [EM] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab 300 mg | Experimental | Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24. |
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| Eptinezumab 100 mg | Experimental | Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | Concentrate for solution for infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Baseline up to Week 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Free Eptinezumab Plasma Concentration | Baseline, Weeks 8, 12, 24, 36, and 44 | |
| Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) | Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 |
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Inclusion Criteria:
- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.
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 University School of Medicine | Recruiting | New Haven | Connecticut | 06511 | United States | |
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| Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) | Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 |
| Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36 | Baseline, Weeks 12, 24, and 36 |
| Ki Health Partners LLC DBA New England Institute for Clinical Research |
| Recruiting |
| Stamford |
| Connecticut |
| 06905-1206 |
| 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 |
| University of Kentucky | Recruiting | Lexington | Kentucky | 40536-7001 | United States |
| University of Maryland School of Medicine | Recruiting | Baltimore | Maryland | 21201-1544 | 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 |
| Helen Devos Childrens' Hospital - PIN | Completed | Grand Rapids | Michigan | 49503-2528 | United States |
| Dent Neurosciences Research Center Incorporated | Completed | Amherst | New York | 14226-1727 | United States |
| True North Neurology | Recruiting | Commack | New York | 11725-2808 | United States |
| OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte | Completed | Charlotte | North Carolina | 28211-5027 | United States |
| Childrens Hospital Medical Center of Akron | Recruiting | Akron | Ohio | 44308-1063 | United States |
| Cincinnati Children's Hospital Medical Center - PIN | Recruiting | Cincinnati | Ohio | 45229-3026 | United States |
| Road Runner Research Ltd | Recruiting | San Antonio | Texas | 78249-3539 | United States |
| Children's Specialty Group - 3 Commercial Place | Recruiting | Norfolk | Virginia | 23510 | United States |
| Marshall University Medical Center | Recruiting | Huntington | West Virginia | 25701-3656 | United States |
| Children's Wisconsin - Milwaukee Campus - PIN | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Hospital Privado de La Comunidad | Completed | Mar del Plata | Buenos Aires | 7603 | 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 |
| 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 |
| IRCCS Ospedale Pediatrico Bambino Gesu | 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 |
| 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 |
| Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara | Recruiting | Pisa | Tuscany | 56126 | Italy |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS | Recruiting | Pavia | 27100 | Italy |
| Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C. | Recruiting | Guadalajara | Jalisco | 44700 | Mexico |
| Clinical Research Institute SC-Mexico | Recruiting | Ampl San Lucas Tepetlacalco | State of Mexico | 54055 | Mexico |
| ICARO Investigaciones en Medicina, S.A de C.V | Recruiting | Chihuahua City | 31000 | Mexico |
| Instituto de Investigationes Clinicas para la Salud A.C. | Recruiting | Durango | 34000 | 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 Santo António, EPE - Centro Materno Infantil Norte | Recruiting | Porto Covo | Setúbal District | 4050-651 | Portugal |
| Centro Clínico Académico, Braga - Hospital de Braga | Recruiting | Braga | 4710-243 | 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 |
| University Clinical Center Nis | Recruiting | Niš | 18 000 | 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 |
| 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) |
| Mersin University Medical Faculty | Recruiting | Mersin | 33169 | Turkey (Türkiye) |
| 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 | G514TF | United Kingdom |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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