A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

Official title

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

Overview

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.

Interventions

• Drug Eptinezumab
  Eptinezumab will be administered per dose and schedule specified in the arm.
• Drug Placebo
  Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Primary outcome measures

• Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 [Time frame: Baseline, Weeks 1-12]

Secondary outcome measures (12)

• Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 [Time frame: Baseline up to Weeks 1-12]
• Percentage of Participants With Migraine on the Day After Dosing (Day 1) [Time frame: Day 1]
• Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12 [Time frame: Baseline, Weeks 1-12]
• Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12 [Time frame: Baseline up to Weeks 1-12]
• Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 [Time frame: Baseline up to Weeks 1-4]
• Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4 [Time frame: Baseline up to Weeks 1-4]
• Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 [Time frame: Baseline, Weeks 1-12]
• Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 [Time frame: Baseline, Weeks 1-12]
• Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12 [Time frame: Baseline, Weeks 1-12]
• Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12 [Time frame: Baseline, Weeks 1-12]
• Free Eptinezumab Plasma Concentration [Time frame: 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]) [Time frame: From randomization (Week 0) up to Week 20]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 22 centers

• Yale-New Haven Children's Hospital - PIN — New Haven
• Ki Health Partners LLC DBA New England Institute for Clinical Research — Stamford
• Children's National Medical Center — Washington D.C.
• NW FL Clinical Research Group, LLC — Gulf Breeze
• AGA Clinical Trials - Hialeah - 4980 W 10th Ave — Hialeah
• Axcess Medical Research — Loxahatchee Groves
• University of South Florida — Tampa
• Clinical Integrative Research Center of Atlanta — Atlanta
• … and 14 more centers

Argentina · 10 centers

• Hospital Privado de La Comunidad — Mar del Plata
• Clínica Privada Independencia — Munro
• Hospital Italiano de Buenos Aires — Ciudad Autónoma Buenos Aires
• Hospital Britanico de Buenos Aires — Buenos Aires
• Sanatorio Allende S.A — Córdoba
• Hospital de Niños de La Santisima Trinidad — Córdoba-Barrio Crisol
• Instituto Médico Río Cuarto — Río Cuarto
• INECO Neurociencias Oroño — Rosario
• … and 2 more centers

Mexico · 9 centers

• Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C. — Guadalajara
• Unidad de Investigación en Salud de Chihuahua S.C. — Zapopan
• Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia — Morelia
• Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city — México
• ICARO Investigaciones en Medicina, S.A de C.V — Chihuahua City
• Neurociencias Estudios Clinicos S.C. — Culiacán Sinaloa
• Instituto de Investigationes Clinicas para la Salud A.C. — Durango
• Clinical Research Institute SC-Mexico — Tepetlacolco
• … and 1 more center

Italy · 8 centers

• Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari
• Ospedale Pediatrico Bambino Gesù IRCCS — Rome
• IRCCS Istituto Giannina Gaslini — Genoa
• Ospedale San Raffaele S.r.l. — Milan
• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
• Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia
• AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza — Cagliari
• Azienda Ospedaliero Universitaria A Meyer (Duplicate) — Florence

Poland · 7 centers

• AthleticoMed — Bydgoszcz
• Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandyto — Krakow
• Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k. — Oświęcim
• MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak — Wroclaw
• ETG Lublin - PPDS — Lublin
• MTZ Clinical Research Powered by PRATIA - PPDS — Warsaw
• ETG Neuroscience - PPDS — Warsaw

Spain · 6 centers

• CHUVI - H.U. Alvaro Cunqueiro — Vigo
• Hospital Universitario Vall d'Hebron - PPDS — Barcelona
• Instituto del Sueño — Madrid
• Hospital Clinico San Carlos — Madrid
• Hospital Universitario Virgen del Rocio - PPDS — Seville
• Hospital Universitari i Politecnic La Fe de Valencia — Valencia

Canada · 5 centers

• University of Alberta — Edmonton
• Medical Arts Health Research Group - Penticton - PPDS — Penticton
• Vancouver Island Health Authority — Victoria
• The Kids Clinic — Ajax
• London Health Sciences Centre -800 Commissioners Rd E — London

Turkey (Türkiye) · 5 centers

• Izmir City Hospital — Bayraklı
• Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi — Eskişehir
• Istanbul Üniversitesi, Istanbul Tip Fakültesi, Nör — Fatih/Istanbul
• Istanbul University Cerrahpasa Medical Faculty Hospital — Fatih/Istanbul
• Mersin University Medical Faculty — Mersin

United Kingdom · 5 centers

• Royal Devon and Exeter Hospital NHS Trust - PPDS — Exeter
• … and 4 more centers

Serbia · 4 centers

• Childrens University Hospital — Belgrade
• University Clinical Center Kragujevac — Kragujevac
• Children and Youth Health Care Institute of Vojvodina — Novi Sad
• Clinical Centre of Vojvodina — Novi Sad

Portugal · 3 centers

• ULS de Almada-Seixal, EPE - Hospital Garcia de Orta — Almada
• ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra — Coimbra
• ULS de São João, EPE - Hospital de São João — Porto

Identifiers

NCT: NCT04965675 · 19356A · 2020-001009-22 · 2024-510656-13-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗