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A Study of Eptinezumab for Episodic Migraine in Children and Teens

This study is looking at whether eptinezumab can help reduce the number of migraine days for children and teenagers (ages 6 to 17) who experience episodic migraines. Participants will receive either eptinezumab or a placebo (an inactive substance) through an infusion. The main goal is to see how much the number of monthly migraine days changes over the first 12 weeks of the study. To join, you must have a diagnosis of migraine for at least 6 months. The study plans to enroll about 315 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves about 315 participants who will receive either eptinezumab or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome measures changes in migraine days over the first 12 weeks of the study.

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NCT05897320

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Recruiting
PHASE3Ages 6–17InterventionalTreatment
H. Lundbeck A/S
~315 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:EptinezumabPlacebo

At a glance

Recruiting sites
52 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Measured over Baseline, Weeks 1-12

Conditions

Episodic Migraine

Explore related trials

Migraine

Where it's being run

64 sites across 42 states
Serbia5
Portugal4
Florida3
Argentina3
Spain3
Turkey (Türkiye)3
Ohio2
British Columbia2

Study leadership

Who to contact

Email contact via H. Lundbeck A/S
[email protected]
+45 36301311
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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).
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.

What this trial measures

  • Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12Baseline, Weeks 1-12