RECRUITING

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

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

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Official Title

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

Quick Facts

Study Start:2021-06-30
Study Completion:2024-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04965675

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:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
  2. * During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
  3. * During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.
  1. * The participant has previously been randomised in this study and exposed to eptinezumab.
  2. * The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
  3. * The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit.
  4. * The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).

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)

Yale-New Haven Children's Hospital
New Haven, Connecticut, 06504-8901
United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, 06905-1206
United States
Children's National Medical Center
Washington, District of Columbia, 20010-2916
United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561-4458
United States
A G A Clinical Trials - HyperCore - PPDS
Hialeah, Florida, 33012-3407
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 HealthCare (UKHC) Kentucky Clinic
Lexington, Kentucky, 40508-1683
United States
University of Maryland
Baltimore, Maryland, 21201
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
Corewell Health
Grand Rapids, Michigan, 49503
United States
Dent Neurosciences Research Center Incorporated
Amherst, New York, 14226-1746
United States
North Suffolk Neurology-Commack
Commack, New York, 11725-2808
United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS
Charlotte, North Carolina, 28211-5027
United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, 45229-3026
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Road Runner Research Ltd
San Antonio, Texas, 78249-3539
United States
Children's Specialty Group
Norfolk, Virginia, 23510-1021
United States
Mary Bridge Children's Hospital
Tacoma, Washington, 98405-4048
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 Date2021-06-30
Study Completion Date2024-10-31

Study Record Updates

Study Start Date2021-06-30
Study Completion Date2024-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Migraine in Children