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A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Purpose

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

Condition

Episodic Migraine

Eligibility

Eligible Ages: Between 6 Years and 17 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Eptinezumab 300 mg	Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).	Drug: Eptinezumab Solution for infusion
Placebo Comparator Placebo	Participants will receive a single IV infusion of matching placebo to eptinezumab.	Drug: Placebo Solution for infusion
Experimental Eptinezumab 100 mg	Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).	Drug: Eptinezumab Solution for infusion

Recruiting Locations

Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut 06905-1206

Child Neurology of NW Florida
Gulf Breeze, Florida 32561-4495

A G A Clinical Trials - HyperCore - PPDS
Hialeah, Florida 33012-3407

University of South Florida
Tampa, Florida 33612

University of Kentucky HealthCare (UKHC) Kentucky Clinic
Lexington, Kentucky 40508-1683

University of Maryland School of Medicine
Baltimore, Maryland 21201-1544

Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan 48104-5131

North Suffolk Neurology-Commack
Commack, New York 11725-2808

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
Charlotte, North Carolina 28211-5027

Childrens Hospital Medical Center of Akron
Akron, Ohio 44308-1063

Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio 45229-3026

Road Runner Research Ltd
San Antonio, Texas 78249-3539

Children's Specialty Group - 3 Commercial Place
Norfolk, Virginia 23510

Childrens Hospital of Wisconsin
New Berlin, Wisconsin 53151-7494

More Details

NCT ID: NCT05897320
Status: Recruiting
Sponsor: H. Lundbeck A/S

Study Contact

Email contact via H. Lundbeck A/S
+45 36301311
LundbeckClinicalTrials@Lundbeck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.