A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Description

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

Conditions

Episodic Migraine

Study Overview

Study Details

Study overview

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

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

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Condition
Episodic Migraine
Intervention / Treatment

-

Contacts and Locations

Stamford

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

Gulf Breeze

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

Hialeah

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

Tampa

University of South Florida, Tampa, Florida, United States, 33612

Lexington

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

Baltimore

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

Ann Arbor

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

Commack

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

Charlotte

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

Akron

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lundbeck A/S,

Email contact via H. Lundbeck A/S, STUDY_DIRECTOR, LundbeckClinicalTrials@Lundbeck.com

Study Record Dates

2024-10-31