A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Episodic Migraine

In brief

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Key facts

Study ID

NCT05897320

Run by

H. Lundbeck A/S

People needed

315

Starts

2023-06-08

Expected to finish

2027-08-31

Last updated by the study team

2026-07-14

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
• During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
• During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.

You may not qualify if…

• History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min).
• History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
• Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
• Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.
• Other inclusion and exclusion criteria may apply.

Where it is running

• Azienda Ospedaliero Universitaria A Meyer (Duplicate) — Florence, Tuscany, Italy (enrolling)
• Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara — Pisa, Tuscany, Italy (enrolling)
• Istituto G Gaslini Ospedale Pediatrico IRCCS — Genoa, Liguria, Italy (enrolling)
• AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza — Cagliari, Sardinia, Italy (enrolling)
• AGA Clinical Trials - Hialeah - 4980 W 10th Ave — Hialeah, Florida, United States (enrolling)
• Ki Health Partners LLC DBA New England Institute for Clinical Research — Stamford, Connecticut, United States (enrolling)
• Ospedale Pediatrico Bambino Gesù IRCCS — Rome, Lazio, Italy (enrolling)
• Child Neurology of NW Florida — Gulf Breeze, Florida, United States (enrolling)
• Ospedale San Raffaele S.r.l. - PPDS — Milan, Lombardy, Italy (enrolling)
• Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia, Lombardy, Italy (enrolling)
• Cincinnati Children's Hospital Medical Center - PIN — Cincinnati, Ohio, United States (enrolling)
• Road Runner Research Ltd — San Antonio, Texas, United States (enrolling)
• Children's Specialty Group - 3 Commercial Place — Norfolk, Virginia, United States (enrolling)
• Childrens Hospital of Wisconsin - PIN — New Berlin, Wisconsin, United States (enrolling)
• University of South Florida - 13330 USF Laurel Dr — Tampa, Florida, United States (enrolling)
• London Health Sciences Centre -800 Commissioners Rd E — London, Ontario, Canada (enrolling)
• Instituto Médico Río Cuarto — Río Cuarto, 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)
• Clinical Integrative Research Center of Atlanta — Atlanta, Georgia, United States (enrolling)
• Hospital de Niños de La Santisima Trinidad — Córdoba, Argentina (enrolling)
• Childrens Hospital Medical Center of Akron — Akron, Ohio, United States (enrolling)
• Vancouver Island Health Authority — Victoria, British Columbia, Canada (enrolling)
• The Kids Clinic — Ajax, Ontario, Canada (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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