Tests eptinezumab to prevent episodic migraine in children
Tests eptinezumab, given intravenously, in children with episodic migraine.
Plain-language title generated from the registry record
Registry title: A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Key facts
- Where
- Akron, Ann Arbor, Atlanta, Baltimore, Charlotte, Cincinnati, Commack, Gulf Breeze, Hialeah, Lexington, Milwaukee, Norfolk, San Antonio, Stamford, and Tampa, United StatesSee the 15 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT05897320, who can take part
Where in United States
- Akron Children's HospitalAkron, United StatesTaking people
- Michigan Headache & Neurological Institute (MHNI)Ann Arbor, United StatesNo longer taking part
- Clinical Integrative Research Center of Atlanta (CIRCAtl)Atlanta, United StatesNo longer taking part
- University of Maryland School of MedicineBaltimore, United StatesNo longer taking part
- OnSite Clinical Solutions, LLC - CharlotteCharlotte, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical Center-Burnet CampusCincinnati, United StatesTaking people
- True North Neurology - Commack (North Suffolk Neurology)Commack, United StatesNo longer taking part
- Child Neurology Center (CNC) of Northwest FloridaGulf Breeze, United StatesTaking people
- AGA Clinical TrialsHialeah, United StatesTaking people
- UK HealthCare-Kentucky ClinicLexington, United StatesNo longer taking part
- Children's Wisconsin (Children's Hospital of Wisconsin)-Main CampusMilwaukee, United StatesTaking people
- Children's Specialty Group (CSG)Norfolk, United StatesTaking people
- Road Runner Research (RRR)San Antonio, United StatesTaking people
- New England Institute for Clinical Research (NEICR) - StamfordStamford, United StatesTaking people
- University of South Florida (USF) - Tampa CampusTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- H. Lundbeck A/S
- Trial code
- NCT05897320EU 2022-502538-14-00
- Record updated
- 14 October 2026
- Original description
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.Read full original descriptionShow less
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Inclusion: 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.
Exclusion: 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); 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; 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; 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.