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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  • 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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Eptinezumab 300 mg 		Participants will receive a single IV infusion of eptinezumab 300 mg (weight adjusted).
  • Drug: Eptinezumab
    Eptinezumab will be administered per dose and schedule specified in the arm.
    Other names:
    • Vyepti
Experimental
Eptinezumab 100 mg 		Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
  • Drug: Eptinezumab
    Eptinezumab will be administered per dose and schedule specified in the arm.
    Other names:
    • Vyepti
Placebo Comparator
Placebo 		Participants will receive a single IV infusion of placebo matching to eptinezumab.
  • Drug: Placebo
    Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Recruiting Locations

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

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

Children's National Medical Center
Washington D.C., District of Columbia 20010-2916

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

AGA Clinical Trials
Hialeah, Florida 33012

University of South Florida
Tampa, Florida 33612-6601

Clinical Integrative Research Center of Atlanta
Atlanta, Georgia 30328-6191

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

University of Maryland
Baltimore, Maryland 21201

Corewell Health Butterworth Hospital
Grand Rapids, Michigan 49503-2560

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

Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio 45229-3026

Road Runner Research Ltd
San Antonio, Texas 78249-3539

Children's Specialty Group
Norfolk, Virginia 23510-1021

Marshall University Medical Center
Huntington, West Virginia 25701-3656

More Details

NCT ID
NCT04965675
Status
Recruiting
Sponsor
H. Lundbeck A/S

Study Contact

Email contact via H. Lundbeck A/S
+45 36301311
HQ_Medinfo@Lundbeck.com

Detailed Description

The study includes a single intravenous (IV) infusion of the study drug and consists of a screening period (4 weeks), a double-blind, placebo-controlled period (12 weeks), and a safety follow-up period (8 weeks). Participants confirmed eligible will be randomized (1:1:1) to receive a single IV infusion of either eptinezumab 300 milligrams (mg) dose (weight adjusted; targeting adult exposure after 300 mg IV), eptinezumab 100 mg (weight adjusted; targeting adult exposure after 100 mg IV), or placebo at randomization visit. The doses will be adjusted for the participant's body weight.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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