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Eptinezumab for treating episodic migraine in children

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

Phase 3 Interventional H. Lundbeck A/S · NCT05897320

This study tests if a new medication called eptinezumab can help reduce the number of migraine days in children who have episodic migraines.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment315 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorH. Lundbeck A/S Industry-sponsored
Drugs / interventionseptinezumab
Locations65 sites (Stamford, Connecticut and 64 other locations)
Trial IDNCT05897320 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of eptinezumab in reducing the frequency of episodic migraine days in pediatric participants. It involves administering either eptinezumab or a placebo to eligible children diagnosed with episodic migraine. Participants will be monitored over a specified period to assess changes in their migraine frequency based on daily headache diaries. The study follows a rigorous methodology to ensure accurate data collection and analysis.

Who should consider this trial

Good fit: Ideal candidates for this study are pediatric patients aged 6 months and older with a diagnosis of episodic migraine and a history of migraine headaches for at least six months.

Not a fit: Patients with chronic tension-type headaches, cluster headaches, or other unusual migraine subtypes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the number of migraine days for children suffering from episodic migraines.

How similar studies have performed: Previous studies on eptinezumab have shown promising results in adult populations, suggesting potential success in pediatric applications.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Stamford, Connecticut and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Episodic Migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.