Actively Recruiting
Study to Evaluate the Efficacy and Safety of Intravenous Eptinezumab in Children and Adolescents With Episodic Migraine
Led by H. Lundbeck A/S · Updated on 2026-03-12
315
Participants Needed
65
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether eptinezumab can reduce the number of migraine days in children and adolescents aged 6 to 17 years with episodic migraine. The study is a randomized, double-blind, placebo-controlled trial designed to assess the preventive effects and safety of intravenous eptinezumab in this pediatric population. It is sponsored by H. Lundbeck AS and is conducted as a Phase 3 trial. Participants will be randomly assigned to receive one of three treatments a single weight-adjusted intravenous infusion of eptinezumab 300 mg, a single infusion of eptinezumab 100 mg, or a placebo infusion. The study compares these groups over the course of 12 weeks following the infusion to evaluate changes in migraine frequency and other related outcomes. During the study, participants and their caregivers will complete headache diaries to track migraine and headache days. Researchers will monitor changes in monthly migraine days averaged over weeks 1 to 12 as the primary outcome. Secondary measures include response rates at various thresholds, headache severity, medication use, and migraine disability scores. Blood samples will be collected at several time points to measure drug levels and immune response. The total participation includes baseline screening and 12 weeks of follow-up after the single infusion treatment.
CONDITIONS
Brief Title
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of migraine (with or without aura) according to International Classification of Headache Disorders, 3rd edition
- History of migraine headaches for at least 6 months prior to screening
- Completion of headache diary for at least 23 of 28 days during screening
- At least 14 headache days in the 28-day screening period
- At least 4 migraine days documented during the 28-day screening period
- Age between 6 and 17 years at enrollment
You will not qualify if you...
- History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes
- History of moderate or severe head trauma or other neurological or systemic medical disorders affecting the central nervous system
- Current uncontrolled or untreated psychiatric condition for at least 6 months prior to screening
- Lifetime history of psychosis or mania
- Any other disorder requiring treatment that takes priority over migraine or could interfere with study treatment or compliance
- Other exclusion criteria as determined by the investigator
Research Team
E
Email contact via H. Lundbeck A/S
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here