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RecruitingPhase 3

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether eptinezumab can reduce the number of migraine days in children and teens. It is for those with episodic migraine, meaning migraines that do not happen every day. Other rules for joining may apply.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have migraines diagnosed by the study doctor, with or without aura (warning signs such as changes in vision), for at least 6 months before screening.
  • Fill out an electronic headache diary on at least 23 of the 28 days after the screening visit, with a parent or caregiver’s help if needed.
  • During those 28 days, record no more than 14 headache days, including at least 4 migraine days.

Who can't join

  • Have certain other headache disorders, such as long-term tension headaches, sleep-related headaches, cluster headaches, constant one-sided headaches, or new headaches that stay every day.
  • Have unusual migraine types, such as those with muscle weakness, certain nerve problems, double vision, changes in awareness, or unusual warning signs lasting over 60 minutes.
  • Have had a moderate or severe head injury, or another illness that the study doctor thinks could affect the brain or spinal cord.
  • Have a mental health condition that has been uncontrolled or untreated for at least 6 months before screening.
  • Have ever had psychosis (trouble knowing what is real) or mania (extreme highs in mood and energy).
  • Have another condition whose treatment must come before migraine care, could interfere with study treatment, or could make it hard to follow treatment instructions.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (15)

CT

FL

GA

KY

MD

MI

NC

NY

OH

TX

VA

WI