A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

Description

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

Conditions

Migraine

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Study Overview

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Study Details

Study overview

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

Condition
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

NW FL Clinical Research Group, LLC, Gulf Breeze, Florida, United States, 32561-4458

Hialeah

A G A Clinical Trials - HyperCore - PPDS, Hialeah, Florida, United States, 33012-3402

Loxahatchee Groves

Axcess Medical Research, Loxahatchee Groves, Florida, United States, 33470-9272

Tampa

University of South Florida, Tampa, Florida, United States, 33612-6601

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536-7001

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

East Lansing

Michigan State University - Department of Neurology, East Lansing, Michigan, United States, 48824-7015

Grand Rapids

Helen Devos Childrens' Hospital, Grand Rapids, Michigan, United States, 49503-2528

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

  • * The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
  • * During lead-in Study19356A or Study19357A:
  • * participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
  • * the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \>5 times the upper limit of the reference range that was confirmed by testing \<2 weeks later.
  • * the participant had a serum ALT or AST value \>3times the upper limit of the reference range and a serum total bilirubin value \>2times the upper limit of the reference range.

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, H. Lundbeck A/S

Study Record Dates

2026-03-01