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A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

RecruitingPhase 3Ages 6 Years - 17 YearsAllH. Lundbeck A/S
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ23 of the 28 days) following the day of the Screening Visit. * During the 28-day screening period, the participant must have โ‰ค14 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.
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What it tests

  • Eptinezumab
  • Placebo
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Where

60 sites
New England Institute for Clinical Research (NEICR) - Stamford
Stamford, United States
Child Neurology Center (CNC) of Northwest Florida
Gulf Breeze, United States
AGA Clinical Trials
Hialeah, United States
University of South Florida (USF) - Tampa Campus
Tampa, United States
Clinical Integrative Research Center of Atlanta (CIRCAtl)
Atlanta, United States
UK HealthCare-Kentucky Clinic
Lexington, United States
University of Maryland School of Medicine
Baltimore, United States
Michigan Headache & Neurological Institute (MHNI)
Ann Arbor, United States

โ€ฆand 52 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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