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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502538-14-00 | Other Identifier | EU CTR |
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The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab 300 mg | Experimental | Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted). |
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| Placebo | Placebo Comparator | Participants will receive a single IV infusion of matching placebo to eptinezumab. |
|
| Eptinezumab 100 mg | Experimental | Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | Solution for infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 | Baseline, Weeks 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Response: ≥50% Reduction From Baseline in MMDs | Baseline, Weeks 1-4 and Weeks 1-12 | |
| Percentage of Participants with Migraine on the Day After Dosing (Day 1) | On Day After Dosing | |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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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 | HQ_Medinfo@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ki Health Partners LLC DBA New England Institute for Clinical Research | Recruiting | Stamford | Connecticut | 06905-1206 | United States |
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| Placebo |
| Drug |
Solution for infusion |
|
| Change From Baseline in MMDs with Acute Medication Use |
| Baseline, Weeks 1-12 |
| Response: ≥75% reduction from baseline in MMDs | Baseline, Weeks 1-4 and Weeks 1-12 |
| Change From Baseline in the Number of Monthly Headache Days (MHDs) | Baseline, Weeks 1-12 |
| Change From Baseline in Monthly Hours with Headache | Baseline, Weeks 1-12 |
| Change From Baseline in Days with Acute Medication | Baseline, Weeks 1-12 |
| Change From Baseline in Rate of Migraines with Severe Pain Intensity | Baseline, Weeks 1-12 |
| Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score | Baseline, Week 12 |
| Free Eptinezumab Plasma Concentrations | Day 0 (pre-dose) and at Weeks 8, 12, and 20 |
| Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) | Day 0 (pre-dose) and at Weeks 8, 12, and 20 |
| Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb) | Day 0 (pre-dose) and at Weeks 8, 12, and 20 |
| Child Neurology of NW Florida | Recruiting | Gulf Breeze | Florida | 32561-4495 | United States |
| AGA Clinical Trials - Hialeah - 4980 W 10th Ave | Recruiting | Hialeah | Florida | 33012 | United States |
| University of South Florida - 13330 USF Laurel Dr | Recruiting | Tampa | Florida | 33620 | United States |
| Clinical Integrative Research Center of Atlanta | Recruiting | Atlanta | Georgia | 30328-6191 | United States |
| University of Kentucky HealthCare (UKHC) Kentucky Clinic | Completed | Lexington | Kentucky | 40508-1683 | 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 |
| 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 |
| 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 |
| Childrens Hospital of Wisconsin - PIN | Recruiting | New Berlin | Wisconsin | 53151-7494 | United States |
| Clínica Privada Independencia | Completed | Munro | Buenos Aires | 1605 | Argentina |
| Hospital Britanico de Buenos Aires | Completed | Barracas | Ciudad Autónoma de BuenosAires | C1280AEB | 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 |
| Hospital de Niños de La Santisima Trinidad | Recruiting | Córdoba | X5000BNB | Argentina |
| 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 |
| Ospedale Pediatrico Bambino Gesù IRCCS | Recruiting | Rome | Lazio | 00165 | Italy |
| Istituto G Gaslini Ospedale Pediatrico IRCCS | Recruiting | Genoa | Liguria | 16147 | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | 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 |
| Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara | Recruiting | Pisa | Tuscany | 56126 | Italy |
| Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia | Recruiting | Morelia | Michoacán | 58260 | Mexico |
| Clinical Research Institute SC-Mexico | Recruiting | Tepetlacolco | 54055 | 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 São João, EPE - Hospital de São João | Recruiting | Porto Covo | Porto District | 4200-319 | 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 |
| Hospital CUF Descobertas | Completed | Lisbon | 1998-018 | 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 | 21000 | 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 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 Universitesi Istanbul Tip Fakultesi Hastanesi | Recruiting | Fatih/Istanbul | 34093 | Turkey (Türkiye) |
| Mersin Universitesi Tip Fakultesi Hastanesi | Recruiting | Mersin | 33169 | Turkey (Türkiye) |
| 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 |
| Royal Hospital for Children (Glasgow) - PPDS - PIN | Recruiting | Glasgow | G514TF | United Kingdom |
| Great Ormond Street Hospital for Children | Recruiting | London | WCIN 3JH | United Kingdom |
| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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