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
Who is this study for? Patients with Migraine
What treatments are being studied? Eptinezumab
Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
Connecticut
Yale-New Haven Children's Hospital - PIN
RECRUITING
New Haven
Ki Health Partners LLC DBA New England Institute for Clinical Research
RECRUITING
Stamford
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Florida
NW FL Clinical Research Group, LLC
RECRUITING
Gulf Breeze
A G A Clinical Trials
RECRUITING
Hialeah
Axcess Medical Research
COMPLETED
Loxahatchee Groves
University of South Florida
RECRUITING
Tampa
Kentucky
University of Kentucky HealthCare (UKHC) Kentucky Clinic
RECRUITING
Lexington
Maryland
University of Maryland
RECRUITING
Baltimore
Michigan
Michigan Head Pain and Neurological Institute
COMPLETED
Ann Arbor
Michigan State University - Department of Neurology
COMPLETED
East Lansing
Corewell Health Butterworth Hospital
RECRUITING
Grand Rapids
North Carolina
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
COMPLETED
Charlotte
New York
Dent Neurosciences Research Center Incorporated
COMPLETED
Amherst
North Suffolk Neurology-Commack
RECRUITING
Commack
Ohio
Cincinnati Children's Hospital Medical Center - PIN
RECRUITING
Cincinnati
Oklahoma
The University of Oklahoma Health Sciences Center
COMPLETED
Oklahoma City
Texas
Road Runner Research Ltd
RECRUITING
San Antonio
Virginia
Children's Specialty Group
RECRUITING
Norfolk
Washington
Mary Bridge Children's Hospital - PIN
COMPLETED
Tacoma
West Virginia
Marshall University Medical Center
RECRUITING
Huntington
Other Locations
Argentina
Expertia S.A- Mautalén Salud e Investigación
RECRUITING
Buenos Aires
Hospital Britanico de Buenos Aires
COMPLETED
Buenos Aires
Hospital Italiano de Buenos Aires
COMPLETED
Ciudad Autónoma Buenos Aires
Sanatorio Allende S.A
COMPLETED
Córdoba
Hospital de Niños de La Santisima Trinidad
RECRUITING
Córdoba-barrio Crisol
Hospital Privado de La Comunidad
COMPLETED
Mar Del Plata
Clínica Privada Independencia
COMPLETED
Munro
Instituto Médico Río Cuarto
RECRUITING
Río Cuarto
INECO Neurociencias Oroño
RECRUITING
Rosario
Centro de Investigaciones Médicas Tucumán - PPDS
RECRUITING
San Miguel De Tucumán
Canada
The Kids Clinic
RECRUITING
Ajax
University of Alberta
COMPLETED
Edmonton
London Health Sciences Centre -800 Commissioners Rd E
RECRUITING
London
Medical Arts Health Research Group - Penticton
COMPLETED
Penticton
Vancouver Island Health Authority
RECRUITING
Victoria
Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico
COMPLETED
Bari
AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
RECRUITING
Cagliari
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
RECRUITING
Florence
IRCCS Istituto Giannina Gaslini
RECRUITING
Genoa
Fondazione IRCCS Istituto Neurologico Carlo Besta
COMPLETED
Milan
Ospedale San Raffaele S.r.l. - INCIPIT - PIN
RECRUITING
Milan
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
RECRUITING
Pavia
Ospedale Pediatrico Bambino Gesù IRCCS
RECRUITING
Rome
Mexico
ICARO Investigaciones en Medicina, S.A de C.V
RECRUITING
Chihuahua City
Neurociencias Estudios Clinicos S.C.
COMPLETED
Culiacán Sinaloa
Instituto de Investigationes Clinicas para la Salud A.C.
RECRUITING
Durango
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
RECRUITING
Guadalajara
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
COMPLETED
Mexico City
Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia
RECRUITING
Morelia
Clinical Research Institute SC-Mexico
RECRUITING
Tepetlacolco
Centro de Estudios Clinicos Y Especialidades Medicas SC
COMPLETED
Vista Hermosa
Unidad de Investigación en Salud de Chihuahua S.C.
COMPLETED
Zapopan
Poland
AthleticoMed
RECRUITING
Bydgoszcz
Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
RECRUITING
Krakow
ETG Lublin - PPDS
RECRUITING
Lublin
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
RECRUITING
Oświęcim
ETG Neuroscience - PPDS
RECRUITING
Warsaw
MTZ Clinical Research Powered by PRATIA - PPDS
RECRUITING
Warsaw
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
RECRUITING
Wroclaw
Portugal
ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
RECRUITING
Almada
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
RECRUITING
Coimbra
ULS de São João, EPE - Hospital de São João
RECRUITING
Porto
Serbia
Childrens University Hospital
RECRUITING
Belgrade
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Children and Youth Health Care Institute of Vojvodina
RECRUITING
Novi Sad
Clinical Centre of Vojvodina
RECRUITING
Novi Sad
Spain
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Instituto del Sueño
COMPLETED
Madrid
Hospital Universitario Virgen del Rocio - PPDS
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
CHUVI - H.U. Alvaro Cunqueiro
RECRUITING
Vigo
Turkey
Izmir City Hospital
RECRUITING
Bayraklı
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
RECRUITING
Eskişehir
Istanbul Üniversitesi, Istanbul Tip Fakültesi, Nör
RECRUITING
Fatih/istanbul
Istanbul University Cerrahpasa Medical Faculty Hospital
COMPLETED
Fatih/istanbul
Mersin University Medical Faculty
RECRUITING
Mersin
United Kingdom
Royal Hospital for Children and Young People - PIN
RECRUITING
Edinburgh
Royal Devon and Exeter Hospital NHS Trust - PPDS
COMPLETED
Exeter
Queen Elizabeth University Hospital - PPDS
RECRUITING
Glasgow
James Paget University Hospitals NHS Foundation Trust
RECRUITING
Great Yarmouth
Great Ormond Street Hospital - PPDS
RECRUITING
London
Contact Information
Primary
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
+45 36301311
Time Frame
Start Date: 2021-06-30
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 285
Treatments
Experimental: Eptinezumab 300 mg
Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).
Experimental: Eptinezumab 100 mg
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Placebo_comparator: Placebo
Participants will receive a single IV infusion of placebo matching to eptinezumab.
Related Therapeutic Areas
Sponsors
Leads: H. Lundbeck A/S