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
- Barcelona, Madrid, and Vigo, SpainSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with episodic migraine, to test whether eptinezumab given into a vein reduces migraine days.
- Age
- 6 to 17 years
- Sex
- All sexes can join.
- Disease stage
- Migraine (with or without aura) for at least 6 months. During the 28-day screening period: 14 or fewer headache days, with at least 4 migraine days.
Main reasons for not taking part
- Other headache types such as chronic tension-type headache, cluster headache or new daily persistent headache
- Unusual migraine types such as hemiplegic migraine or migraine with brainstem aura
- Moderate or severe head injury, or another brain or body illness likely to affect the nervous system
- Psychiatric condition that is uncontrolled or untreated for 6 months, or past psychosis or mania
- Another disorder whose treatment comes before migraine treatment or could interfere with the trial
Read by machine on 9 November 2026.
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 Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Clínico San CarlosMadrid, SpainTaking people
- Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC)Vigo, SpainTaking 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.