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Recruiting Phase 3 NCT05897320

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Trial Parameters

Condition Episodic Migraine
Sponsor H. Lundbeck A/S
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 315
Sex ALL
Min Age 6 Years
Max Age 17 Years
Start Date 2023-06-08
Completion 2027-07-06
Interventions
EptinezumabPlacebo

Brief Summary

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

Eligibility 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 neuropat

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