A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
- Registration Number
- NCT04965675
- Lead Sponsor
- H. Lundbeck A/S
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 285
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eptinezumab 300 mg Eptinezumab Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted). Placebo Placebo Participants will receive a single IV infusion of placebo matching to eptinezumab. Eptinezumab 100 mg Eptinezumab Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
- Primary Outcome Measures
Name Time Method Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 Baseline, Weeks 1-12
- Secondary Outcome Measures
Name Time Method Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 Baseline, Weeks 1-12 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 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 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 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 1-4 Baseline up to Weeks 1-4 Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 Baseline up to Weeks 1-12 Change From Baseline in Monthly Headache Days 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 Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12 Baseline, Weeks 1-12 Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) From randomization (Week 0) up to Week 20
Trial Locations
- Locations (73)
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
🇮🇹Firenze, Toscana, Italy
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
🇲🇽Guadalajara, Jalisco, Mexico
AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
🇮🇹Cagliari, Sardegna, Italy
Unidad de Investigacion en Salud de Chihuahua S.C.
🇲🇽Zapopan, Jalisco, Mexico
Corewell Health Butterworth Hospital
🇺🇸Grand Rapids, Michigan, United States
Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia
🇲🇽Morelia, Michoacan, Mexico
ICARO Investigaciones en Medicina, S.A de C.V
🇲🇽Chihuahua, Mexico
Neurociencias Estudios Clinicos S.C.
🇲🇽Culiacan Sinaloa, Mexico
Instituto de Investigationes Clinicas para la Salud A.C.
🇲🇽Durango, Mexico
Unidad de Investigacion en Salud de Chihuahua S.C.-Mexico city
🇲🇽Mexico City, Mexico
ULS de Coimbra, EPE - Hospital Pediatrico de Coimbra
🇵🇹Coimbra, Portugal
ULS de São João, EPE - Hospital de São João
🇵🇹Porto, Portugal
Clinical Research Institute SC-Mexico
🇲🇽Tepetlacalco, Mexico
Centro de Estudios Clinicos Y Especialidades Medicas SC
🇲🇽Vista Hermosa, Mexico
ULS de Almada-Seixal, EPE - Hospital Garcia de Orta
🇵🇹Almada, Setúbal, Portugal
Childrens University Hospital
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Children and Youth Health Care Institute of Vojvodina
🇷🇸Novi Sad, Serbia
Clinical Centre of Vojvodina
🇷🇸Novi Sad, Serbia
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Instituto del Sueño
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio - PPDS
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
🇹🇷Eskisehir, Turkey
Istanbul University Cerrahpasa Medical Faculty Hospital
🇹🇷Fatih/Istanbul, Turkey
Mersin University Medical Faculty
🇹🇷Mersin, Turkey
Royal Devon and Exeter Hospital NHS Trust
🇬🇧Exeter, Devon, United Kingdom
Queen Elizabeth University Hospital - PPDS
🇬🇧Glasgow, Lanarkshire, United Kingdom
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
Izmir City Hospital
🇹🇷Bayrakli, Izmir, Turkey
Yale-New Haven Children's Hospital
🇺🇸New Haven, Connecticut, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
NW FL Clinical Research Group, LLC
🇺🇸Gulf Breeze, Florida, United States
A G A Clinical Trials - HyperCore - PPDS
🇺🇸Hialeah, Florida, United States
Axcess Medical Research
🇺🇸Loxahatchee Groves, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Kentucky HealthCare (UKHC) Kentucky Clinic
🇺🇸Lexington, Kentucky, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Michigan State University - Department of Neurology
🇺🇸East Lansing, Michigan, United States
Dent Neurosciences Research Center Incorporated
🇺🇸Amherst, New York, United States
North Suffolk Neurology-Commack
🇺🇸Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
🇺🇸Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center - PIN
🇺🇸Cincinnati, Ohio, United States
The University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Road Runner Research Ltd
🇺🇸San Antonio, Texas, United States
Children's Specialty Group
🇺🇸Norfolk, Virginia, United States
Mary Bridge Children's Hospital
🇺🇸Tacoma, Washington, United States
Marshall University Medical Center
🇺🇸Huntington, West Virginia, United States
Hospital Privado de La Comunidad
🇦🇷Mar Del Plata, Buenos Aires, Argentina
Clínica Privada Independencia
🇦🇷Munro, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autonoma Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina
Expertia S.A- Mautalén Salud e Investigacion
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires, Argentina
Sanatorio Allende S.A
🇦🇷Ciudad De Cordoba, Cordoba, Argentina
Hospital de Niños de La Santisima Trinidad
🇦🇷Cordoba-Barrio Crisol, Cordoba, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Cordoba, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Centro de Investigaciones Médicas Tucuman - PPDS
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Medical Arts Health Research Group - Penticton
🇨🇦Penticton, British Columbia, Canada
Vancouver Island Health Authority
🇨🇦Victoria, British Columbia, Canada
The Kids Clinic
🇨🇦Ajax, Ontario, Canada
Ospedale Pediatrico Bambino Gesù IRCCS
🇮🇹Roma, Lazio, Italy
IRCCS Istituto Giannina Gaslini
🇮🇹Genova, Liguria, Italy
Ospedale San Raffaele S.r.l. - INCIPIT - PIN
🇮🇹Milano, Lombardia, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
🇮🇹Pavia, Lombardia, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico
🇮🇹Bari, Puglia, Italy
Great Ormond Street Hospital for Children
🇬🇧London, London, City Of, United Kingdom
James Paget University Hospitals NHS Foundation Trust
🇬🇧Great Yarmouth, Norfolk, United Kingdom