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Eptinezumab for Migraine in Children and Adolescents

This study is looking at the long-term safety of eptinezumab, a medication given through an IV, for children and adolescents aged 6 to 17 who experience chronic (frequent) or episodic (occasional) migraines. You can join this study if you have already completed a previous study (Study 19356A or Study 19357A) involving eptinezumab. The main goal is to track any side effects or safety concerns that might happen while taking eptinezumab over time. This study plans to include about 600 participants. The current recruitment status is unclear.

Study design
This is an open-label extension study, meaning everyone knows what treatment they are receiving. It is for participants who completed a previous study.
What's involved
You would continue to receive eptinezumab, either at a 100 mg or 300 mg dose (adjusted for weight), through an IV. The study will track your safety from the start up to Week 44.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events (side effects) from the start of the study up to Week 44.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05164172

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

Recruiting
PHASE3Ages 6–17InterventionalTreatment
H. Lundbeck A/S
~600 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Eptinezumab

At a glance

Recruiting sites
61 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Treatment Emergent Adverse Events
Measured over Baseline up to Week 44

Conditions

Migraine

Explore related trials

Migraine

Where it's being run

70 sites across 44 states
Serbia5
Florida4
Spain4
Michigan3
Portugal3
Connecticut2
New York2
Ohio2

Study leadership

  • Email contact via H. Lundbeck A/S · STUDY_DIRECTOR · H. Lundbeck A/S

Who to contact

Email contact via H. Lundbeck A/S
[email protected]
+45 36301311
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
During lead-in Study19356A or Study19357A:
participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later.
the participant had a serum ALT or AST value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.

What this trial measures

  • Number of Participants With Treatment Emergent Adverse EventsBaseline up to Week 44