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

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.

Conditions

Chronic Migraine in Children

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Migraine in Children
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale-New Haven Children's Hospital, New Haven, Connecticut, United States, 06504-8901

Stamford

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

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010-2916

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, 33012-3407

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

Baltimore

University of Maryland, Baltimore, Maryland, United States, 21201

Ann Arbor

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

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 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.
  • * 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.
  • * 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.
  • * The participant has previously been randomised in this study and exposed to eptinezumab.
  • * The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
  • * 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.
  • * 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).

Ages Eligible for Study

12 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

2024-10-31