Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Sponsor: H. Lundbeck A/S

NCT ID: NCT05897320

View on ClinicalTrials.gov ↗

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 50 months (dates as stated)
About the drug or intervention
Eptinezumab — drug: Solution for infusion · Placebo — drug: Solution for infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
6 Years to 17 Years
Who
All
Number of participants
315
Started
2023-06-08
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for episodic migraine
  • • Phase3 - 315 participants
  • • The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants

Who can take part?

  • • Ages 6 Years to 17 Years
  • • Diagnosed with episodic migraine

Where?

  • • Edinburgh - NHS Lothian - Royal Hospital for Children & Young People (RHCYP)
  • • Great Yarmouth - James Paget University Hospitals NHS Foundation Trust
  • • Glasgow - NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...
  • • London - Great Ormond Street Hospital for Children NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Episodic Migraine

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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:

  • ✓ ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary

Treatments you must NOT have had:

  • ✗ to the Screening Visit. Participants with a lifetime history of psychosis and/or mania

What the study is looking for

  • ✓During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine...

Who cannot take part

  • ✗Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening...
  • ✗Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with...
  • ✗Other inclusion and exclusion criteria may apply.
See the full criteria
Inclusion Criteria: * Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit. * During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit. * During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary. Exclusion Criteria: * History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min). * History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system. * Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded. * Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance. Other inclusion and exclusion criteria may apply.

Where Is This Study? (4 UK sites)

NHS Lothian - Royal Hospital for Children & Young People (RHCYP)

Edinburgh EH16 4TJ, United Kingdom

Recruiting

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth NR31 6LA, United Kingdom

Recruiting
Hospital R&D contact (matched)

rd.office@jpaget.nhs.uk

rd.office@jpaget.nhs.uk01493 453478

NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...

Glasgow G51 4TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

Great Ormond Street Hospital for Children NHS Foundation Trust

London WC1N 3JH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

How to Get in Touch

Email contact via H. Lundbeck A/S

Sponsor contact

CONTACT

+45 36301311 HQ_Medinfo@Lundbeck.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09