A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Launched by H. LUNDBECK A/S · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called eptinezumab to see if it can help reduce the number of days children and teenagers experience episodic migraines, which are headaches that come and go rather than being constant. The trial is currently looking for participants aged 2 to 17 who have been diagnosed with migraines for at least six months. To be eligible, participants must have had fewer than 14 headache days in the past month, and at least 4 of those must have been migraine days as tracked in a headache diary.

If your child participates, they will be asked to complete a headache diary for 28 days to record their headache days. This helps the researchers understand how well eptinezumab works. Participants will also receive regular check-ins with healthcare providers throughout the study. It's important to note that children with certain other types of headaches, neurological disorders, or untreated psychiatric conditions may not be eligible for this trial. Overall, this study aims to find effective ways to help young people manage their migraines better.

Gender

ALL

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 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.