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), Placebo (drug)
- How long the study runs
- Study runs about 64 months (dates as stated)
- About the drug or intervention
- Eptinezumab — drug: Eptinezumab will be administered per dose and schedule specified in the arm. · Placebo — drug: Placebo matching to eptinezumab will be administered per schedule specified in the arm.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a medicine called eptinezumab in young people aged 12 to 17 who have chronic migraine. Chronic migraine means having headaches on many days each month. The study is funded by H. Lundbeck A/S.
Who can take part
- A diagnosis of migraine (with or without aura) based on international headache guidelines, with chronic migraine for at least 6 months before screening
- During the 28-day screening period, filling in a headache electronic diary on at least 23 of the 28 days
- Having between 15 and 26 headache days during the 28-day screening period, with at least 8 of those being migraine days, as recorded in the diary
Who may not be able to
- Having already taken part in this study and received eptinezumab
- Having had any monoclonal antibody treatment (including in a study) in the 6 months before screening
- Having had another calcitonin gene-related peptide (CGRP) antibody treatment (including in a study) in the 6 months before screening
- Having certain other headache types, such as complicated migraine, chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine types such as hemiplegic migraine or migraine with brainstem aura
What taking part involves
- • Not stated — ask the trial team
Time commitment: Taking part involves a 28-day screening period with a daily headache electronic diary; other details about visits and total study length are 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
- 12 Years to 17 Years
- Who
- All
- Number of participants
- 285
- Started
- 2021-06-30
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for chronic migraine in children
- • Phase3 - 285 participants
- • To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine
Who can take part?
- • Ages 12 Years to 17 Years
- • Diagnosed with chronic migraine in children
Where?
- • Exeter - Royal Devon and Exeter Hospital NHS Trust - PPDS
- • Edinburgh - Royal Hospital for Children and Young People - PIN
- • Great Yarmouth - James Paget University Hospitals NHS Foundation Trust
- • Glasgow - NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
More detail
The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.
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: 12 Years - 17 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary
What the study is looking for
- ✓During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of...
Who cannot take part
- ✗The participant has previously been randomly assigned in this study and exposed to eptinezumab.
- ✗The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months...
- ✗The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a...
See the full criteria
Where Is This Study? (5 UK sites)
Royal Devon and Exeter Hospital NHS Trust - PPDS
Exeter EX2 5DW, United Kingdom
Royal 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
NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi...
Glasgow G51 4TF, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700How to Get in Touch
Email contact via H. Lundbeck A/S
Sponsor contactCONTACT