Under construction – not a live service
Sign in
Taking people in MexicoPhase 3

Tests eptinezumab to prevent episodic migraine in children

Tests eptinezumab, given intravenously, in children with episodic migraine.

Key facts

Who runs it
H. Lundbeck A/S
Where
Morelia and Tepetlacolco, MexicoSee the 2 sitesAlso in 10 other countries, 58 sites
Registry title
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Status
Recruiting
Phase
Phase 3
People taking part
315 people, planned
Started
8 Jun 2023
Expected to end
31 Aug 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Eptinezumab
  • Placebo
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 with episodic migraine, to test whether eptinezumab given into a vein reduces migraine days.

Age
6 to 17 years
Sex
All sexes can join.
Disease stage
Migraine (with or without aura) for at least 6 months. During the 28-day screening period: 14 or fewer headache days, with at least 4 migraine days.

Main reasons for not taking part

  • Other headache types such as chronic tension-type headache, cluster headache or new daily persistent headache
  • Unusual migraine types such as hemiplegic migraine or migraine with brainstem aura
  • Moderate or severe head injury, or another brain or body illness likely to affect the nervous system
  • Psychiatric condition that is uncontrolled or untreated for 6 months, or past psychosis or mania
  • Another disorder whose treatment comes before migraine treatment or could interfere with the trial

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • 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
  • 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

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 Mexico

Also in 10 other countries, 58 sites

  • Centro de Investigacion Clinica de Morelia, S.C.Morelia, MexicoNo longer taking part
  • Clinical Research Institute SC-MexicoTepetlacolco, MexicoTaking people

About the trial

What the trial wants to find out

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

The 3 groups in the trial

  • Eptinezumab 300 mgTreatment being tested

    Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).

    Treatment: Eptinezumab

  • PlaceboPlacebo, for comparison

    Participants will receive a single IV infusion of matching placebo to eptinezumab.

  • Eptinezumab 100 mgTreatment being tested

    Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

    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
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine
Plain-language title
Tests eptinezumab to prevent episodic migraine in childrenGenerated 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 NCT05897320, who can take part
Record updated
14 October 2026