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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Migraine in Children

In brief

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.

Key facts

Study ID

NCT04965675

Run by

H. Lundbeck A/S

People needed

285

Starts

2021-06-30

Expected to finish

2026-10-31

Last updated by the study team

2026-07-14

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• The Kids Clinic — Ajax, Ontario, Canada (enrolling)
• Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C. — Guadalajara, Jalisco, Mexico (enrolling)
• Instituto Médico Río Cuarto — Río Cuarto, Córdoba Province, Argentina (enrolling)
• Vancouver Island Health Authority — Victoria, British Columbia, Canada (enrolling)
• Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia, Lombardy, Italy (enrolling)
• Azienda Ospedaliero Universitaria A Meyer (Duplicate) — Florence, Tuscany, Italy (enrolling)
• NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States (enrolling)
• Hospital de Niños de La Santisima Trinidad — Córdoba-Barrio Crisol, Córdoba Province, Argentina (enrolling)
• INECO Neurociencias Oroño — Rosario, Santa Fe Province, Argentina (enrolling)
• Centro de Investigaciones Médicas Tucumán - PPDS — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• IRCCS Istituto Giannina Gaslini — Genoa, Liguria, Italy (enrolling)
• Ospedale San Raffaele S.r.l. — Milan, Lombardy, Italy (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza — Cagliari, Sardinia, Italy (enrolling)
• Clinical Integrative Research Center of Atlanta — Atlanta, Georgia, United States (enrolling)
• Cincinnati Children's Hospital Medical Center - PIN — Cincinnati, Ohio, United States (enrolling)
• University of Kentucky HealthCare (UKHC) Kentucky Clinic — Lexington, Kentucky, United States (enrolling)
• Road Runner Research Ltd — San Antonio, Texas, United States (enrolling)
• Children's Specialty Group — Norfolk, Virginia, United States (enrolling)
• AGA Clinical Trials - Hialeah - 4980 W 10th Ave — Hialeah, Florida, United States (enrolling)
• Marshall University Medical Center — Huntington, West Virginia, United States (enrolling)
• Ki Health Partners LLC DBA New England Institute for Clinical Research — Stamford, Connecticut, United States (enrolling)
• London Health Sciences Centre -800 Commissioners Rd E — London, Ontario, Canada (enrolling)
• Ospedale Pediatrico Bambino Gesù IRCCS — Rome, Lazio, Italy (enrolling)
• Centro de Investigacion Clinica Chapultepec S.A. de C.V. - Morelia — Morelia, Michoacán, Mexico (enrolling)

Full record on ClinicalTrials.gov

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