Eptinezumab for treating episodic migraine in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of eptinezumab in reducing the frequency of episodic migraine days in pediatric participants. It involves administering either eptinezumab or a placebo to eligible children diagnosed with episodic migraine. Participants will be monitored over a specified period to assess changes in their migraine frequency based on daily headache diaries. The study follows a rigorous methodology to ensure accurate data collection and analysis.

Why it matters

Who can join: the full rules

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 it's running

• New England Institute for Clinical Research (NEICR) - Stamford
  Stamford, Connecticut, United States Recruiting
• Child Neurology Center (CNC) of Northwest Florida
  Gulf Breeze, Florida, United States Recruiting
• AGA Clinical Trials
  Hialeah, Florida, United States Recruiting
• University of South Florida (USF) - Tampa Campus
  Tampa, Florida, United States Recruiting
• Akron Children's Hospital
  Akron, Ohio, United States Recruiting
• Cincinnati Children's Hospital Medical Center-Burnet Campus
  Cincinnati, Ohio, United States Recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Email contact via H. Lundbeck A/S
• Email: HQ_Medinfo@Lundbeck.com
• Phone: +45 36301311

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gou-Teng-San (GTS) for adults with episodic migraine

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• Early Eptinezumab for Acute Post-Traumatic Headache

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  Recruiting at 25 sites Hospital Universitari Vall d'Hebron Research Institute · Miami, Florida and 25 other locations · NCT07159750

• i-NEED: New migraine drugs database

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• Effects of Atogepant on Neurophysiology and Biomolecules in Migraine

  This study is testing if a new migraine medication called atogepant can change brain activity and biochemistry in people who have frequent migraines.

  Recruiting IRCCS National Neurological Institute "C. Mondino" Foundation · Pavia, PAVIA · NCT06882122

• Analyzing CGRP Levels in Migraine Patients by Age and Sex

  This study looks at the levels of a substance linked to migraines in people with migraines and healthy individuals to see how age and sex might affect treatment responses.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT06674772

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.