What is eptinezumab studying for migraine in children and adolescents?

Eptinezumab is being studied to understand its long-term safety in children and adolescents aged 6 to 17 who have chronic or episodic migraine. The research aims to evaluate how the medication affects this younger group over an extended period. The study is sponsored by H. Lundbeck A/S and focuses on monitoring safety outcomes.

Who may be eligible for this migraine clinical trial?

Children and adolescents aged 6 to 17 who have completed Week 12 of specific prior migraine studies may be eligible. Participants must not have serious safety concerns or severe allergic reactions from earlier treatments. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this migraine clinical trial?

Study-related care, including the study drug eptinezumab and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 6Years - 17Years

All Genders

ID05164172

Long-term, Open-label Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

Led by H. Lundbeck A/S · Updated on 2026-04-15

600

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term safety of eptinezumab in children and adolescents aged 6 to 17 years who have chronic or episodic migraine. This phase 3 open-label extension study includes participants who completed prior studies focused on chronic or episodic migraine treatment. The goal is to monitor safety outcomes over an extended period to better understand the effects of eptinezumab in this younger population. Participants will receive eptinezumab by intravenous infusion in one of two weight-adjusted dose groups 100 mg or 300 mg. Those who were previously assigned to a dose in the lead-in study will continue with the same dose, while those who received placebo will be randomly assigned to either dose group. Infusions are given at Weeks 0, 12, and 24 during the study. During the study, participants will be monitored through various assessments including blood tests for eptinezumab levels and antibodies, and a Pediatric Migraine Disability Assessment Questionnaire at multiple timepoints. Safety will be tracked from baseline up to Week 44 by recording any treatment emergent adverse events. The study lasts over several months, with follow-ups scheduled through Week 44 to evaluate long-term safety and impact on migraine-related disability.

CONDITIONS

Brief Title

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

Who Can Participate

Age: 6Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

The participant must have completed Week 12 visit of either Study 19356A (chronic migraine) or Study 19357A (episodic migraine) immediately before enrolling in this extension study.

You will not qualify if you...

The participant has an adverse event or safety concern related to treatment in the previous study considered a potential safety risk.
The participant experienced an anaphylactic or other severe hypersensitivity reaction to the study drug infusion during the prior study.
The participant had liver enzyme (ALT or AST) values over 5 times the upper limit of normal confirmed within 2 weeks.
The participant had ALT or AST values over 3 times the upper limit of normal with total bilirubin over 2 times the upper limit of normal during the prior study.

Research Team

Email contact via H. Lundbeck A/S

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