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Eptinezumab treatment for adolescents with chronic migraine

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

Phase 3 Interventional H. Lundbeck A/S · NCT04965675

This study is testing if a single infusion of eptinezumab can help reduce the number of migraine days for adolescents aged 12 to 17 who suffer from chronic migraines.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment285 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorH. Lundbeck A/S Industry-sponsored
Drugs / interventionseptinezumab
Locations84 sites (New Haven, Connecticut and 83 other locations)
Trial IDNCT04965675 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of eptinezumab, administered as a single intravenous infusion, in reducing the number of migraine days in adolescents aged 12 to 17 with chronic migraine. Participants will be randomized to receive either eptinezumab at two different doses or a placebo over a 12-week period, following a 4-week screening phase. The study aims to determine if eptinezumab is superior to placebo in managing chronic migraines in this age group. Safety will be monitored during an 8-week follow-up period after treatment.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 17 who have a diagnosis of chronic migraine and experience 15 to 26 headache days per month.

Not a fit: Patients who have previously been treated with eptinezumab or other CGRP antibodies within the last 6 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of migraine days in adolescents, improving their quality of life.

How similar studies have performed: Previous studies on eptinezumab in adults have shown promising results, indicating potential success in this adolescent population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
* During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
* During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

Exclusion Criteria:

* The participant has previously been randomised in this study and exposed to eptinezumab.
* The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
* The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit.
* The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).

Where this trial is running

New Haven, Connecticut and 83 other locations

+34 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 Chronic Migraine in Children
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.