At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Eptinezumab (drug)
- How long the study runs
- Study runs about 76 months (dates as stated)
- About the drug or intervention
- Eptinezumab — drug: Concentrate for solution for infusion
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a medicine called eptinezumab in children and teenagers aged 6 to 17 who have chronic (long-term) or episodic (occasional) migraine. It is for people who have already finished a previous migraine study. The study is paid for (sponsored) by a company called H. Lundbeck A/S.
Who can take part
- The child or teenager must have finished the Week 12 visit of a previous migraine study (called Study19356A for chronic migraine, or Study19357A for episodic migraine) just before joining this study.
Who may not be able to
- Having side effects or safety worries linked to the treatment in the earlier study that the study doctor thinks could be a risk.
- Having had a severe allergic reaction (called anaphylaxis) or another serious hypersensitivity reaction to the study medicine given by infusion (a drip into a vein) during the earlier study.
- Having very high levels of certain liver blood tests (called ALT or AST) during the earlier study — more than 5 times the normal limit, confirmed by a repeat test within 2 weeks.
- Having liver blood test results (ALT or AST) more than 3 times the normal limit together with a bile pigment test (called bilirubin) more than 2 times the normal limit.
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 6 Years to 17 Years
- Who
- All
- Number of participants
- 600
- Started
- 2021-12-01
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for migraine
- • Phase3 - 600 participants
- • 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
Who can take part?
- • Ages 6 Years to 17 Years
- • Diagnosed with migraine
Where?
- • London - Great Ormond Street Hospital - PPDS
- • Edinburgh - Royal Hospital for Children and Young People - PIN
- • Great Yarmouth - James Paget University Hospitals NHS Foundation Trust
- • Glasgow - Queen Elizabeth University Hospital - PPDS
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine \[CM\] study in adolescents) or 19357A (episodic migraine \[EM\] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years - 17 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately
What the study is looking for
- ✓\- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM)...
Who cannot take part
- ✗During lead-in Study19356A or Study19357A:
- ✗participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the...
- ✗the participant had a serum alanine aminotransferase (liver enzymes) or aspartate aminotransferase(liver enzymes) value \>5 times the...
- ✗the participant had a serum liver enzymes or liver enzymes value \>3times the upper limit of the reference range and a serum total...
See the full criteria
Where Is This Study? (4 UK sites)
Great Ormond Street Hospital - PPDS
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700Royal Hospital for Children and Young People - PIN
Edinburgh EH16 4TJ, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth NR31 6LA, United Kingdom
Queen Elizabeth University Hospital - PPDS
Glasgow G514TF, United Kingdom
How to Get in Touch
Email contact via H. Lundbeck A/S
Sponsor contactCONTACT