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Taking people in TürkiyePhase 3

Long-term study of eptinezumab for migraine in children and teens

Tests eptinezumab's long-term safety in children and teens with migraine.

Key facts

Who runs it
H. Lundbeck A/S
Where
Eskişehir, Izmir, and Mersin, TürkiyeSee the 3 sitesAlso in 10 other countries, 68 sites
Registry title
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
Status
Recruiting
Phase
Phase 3
People taking part
600 people, planned
Started
1 Dec 2021
Expected to end
30 Apr 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Eptinezumab
Record updated
14 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 6 to 17 with chronic or episodic migraine who finished a previous eptinezumab study. It checks the long-term safety of eptinezumab.

Age
6 to 17 years
Sex
All sexes can join.
Disease stage
Chronic or episodic migraine
Earlier treatment
Must have finished the Week 12 visit of study 19356A (chronic migraine) or study 19357A (episodic migraine) right before joining this study.

Main reasons for not taking part

  • An adverse event or safety concern linked to the double-blind treatment in the earlier study that the investigator sees as a safety risk
  • A severe or serious allergic reaction to the study drug infusion in the earlier study
  • Liver test results (ALT or AST) above 5 times the upper limit of the reference range, confirmed by a repeat test less than 2 weeks later, in the earlier study
  • ALT or AST above 3 times the upper limit together with total bilirubin above 2 times the upper limit in the earlier study

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study

Who cannot take part

  • 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
  • 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
  • During lead-in Study19356A or Study19357A:

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

Where in Türkiye

Also in 10 other countries, 68 sites

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)Eskişehir, TürkiyeTaking people
  • İzmir Şehir HastanesiIzmir, TürkiyeTaking people
  • Mersin Universitesi Tip FakultesiMersin, TürkiyeTaking people

About the trial

What the trial wants to find out

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

The 2 groups in the trial

  • Eptinezumab 300 mgTreatment being tested

    Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.

    Treatment: Eptinezumab

  • Eptinezumab 100 mgTreatment being tested

    Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.

    Treatment: Eptinezumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine
Plain-language title
Long-term study of eptinezumab for migraine in children and teensGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05164172, who can take part
Record updated
14 October 2026