RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-12-01

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05164172

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.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311

LundbeckClinicalTrials@Lundbeck.com

Principal Investigator

Email contact via H. Lundbeck A/S

STUDY_DIRECTOR

H. Lundbeck A/S

Study Locations (Sites)

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, 06905-1206

United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, 32561-4458

United States

A G A Clinical Trials - HyperCore - PPDS

Hialeah, Florida, 33012-3402

United States

Axcess Medical Research

Loxahatchee Groves, Florida, 33470-9272

United States

University of South Florida

Tampa, Florida, 33612-6601

United States

University of Kentucky

Lexington, Kentucky, 40536-7001

United States

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1544

United States

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, 48104-5131

United States

Michigan State University - Department of Neurology

East Lansing, Michigan, 48824-7015

United States

Helen Devos Childrens' Hospital

Grand Rapids, Michigan, 49503-2528

United States

Dent Neurosciences Research Center Incorporated

Amherst, New York, 14226-1727

United States

True North Neurology

Commack, New York, 11725-2808

United States

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS

Charlotte, North Carolina, 28211-5027

United States

Road Runner Research Ltd

San Antonio, Texas, 78249-3539

United States

Marshall University Medical Center

Huntington, West Virginia, 25701-3656

United States

Collaborators and Investigators

Sponsor: H. Lundbeck A/S

Email contact via H. Lundbeck A/S, STUDY_DIRECTOR, H. Lundbeck A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2021-12-01

Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

Migraine