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

Migraine Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164172
• Other study ID #: 19379A
• Secondary ID: 2022-502917-27-0
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is an extension study for participants aged 6 to 17 with migraine who completed either studies 19356A (NCT04965675) (chronic migraine [CM] study in adolescents) or 19357A (episodic migraine [EM] study in children and adolescents). All participants who complete the Week 12 visit of the respective lead-in study will be offered participation in this open-label extension (OLE) study, unless there is a safety concern precluding a participant's participation in the study. Participants originally randomized to 100 milligrams (mg) (weight adjusted) in the double-blind lead-in study (Study 19356A or Study 19357A) will continue on the same dose (100 mg, weight adjusted) in the OLE study. Participants randomized to the 300 mg dose (weight adjusted) in the double-blind lead-in study will continue on 300 mg (weight adjusted) in the OLE study. Participants who were assigned to placebo in the double-blind lead-in study will be randomly allocated to one of the two treatment groups: eptinezumab 100 mg (weight adjusted) or eptinezumab 300 mg (weight adjusted) with a ratio of 1:1.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

Exclusion 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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Eptinezumab
Concentrate for solution for infusion

Locations

Country	Name	City	State
Argentina	Expertia S.A- Mautalen Salud e Investigacion	Ciudad Autonoma de Buenos Aires	Ciudad Autonoma De BuenosAires
Argentina	Hospital de Niños de La Santisima Trinidad	Cordoba-Barrio Crisol	Cordoba
Argentina	Hospital Privado de La Comunidad	Mar Del Plata	Buenos Aires
Argentina	Instituto Médico Río Cuarto	Río Cuarto	Cordoba
Argentina	INECO Neurociencias Orono	Rosario	Santa Fe
Argentina	Centro de Investigaciones Médicas Tucuman	San Miguel de Tucuman	Tucuman
Canada	The Kids Clinic	Ajax	Ontario
Canada	Vancouver Island Health Authority	Victoria	British Columbia
Italy	AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN	Cagliari	Sardegna
Italy	Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN	Firenze	Toscana
Italy	Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico	Genova	Liguria
Italy	Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3	Milano	Lombardia
Italy	Ospedale San Raffaele S.r.l. - INCIPIT - PIN	Milano	Lombardia
Italy	Fondazione Istituto Neurologico Mondino IRCCS	Pavia
Mexico	Clinical Research Institute	Ampl San Lucas Tepetlacalco	México
Mexico	Instituto de Investigationes Clinicas para la Salud A.C.	Durango
Mexico	Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.	Guadalajara	Jalisco
Portugal	Hospital Pediatrico de Coimbra	Coimbra
Serbia	Childrens University Hospital	Beograd	Belgrade
Serbia	Children and Youth Health Care Institute of Vojvodina	Novi Sad
Spain	Hospital Universitario Vall d'Hebron - PPDS	Barcelona
Spain	Hospital Universitario Virgen del Rocio - PPDS	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
United Kingdom	Queen Elizabeth University Hospital - PPDS	Glasgow
United Kingdom	James Paget University Hospitals NHS Foundation Trust	Great Yarmouth	Norfolk
United States	Dent Neurosciences Research Center Incorporated	Amherst	New York
United States	Michigan Head Pain and Neurological Institute	Ann Arbor	Michigan
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS	Charlotte	North Carolina
United States	North Suffolk Neurology-Commack	Commack	New York
United States	Michigan State University - Department of Neurology	East Lansing	Michigan
United States	Helen DeVos Children Hospital	Grand Rapids	Michigan
United States	NW FL Clinical Research Group, LLC	Gulf Breeze	Florida
United States	A G A Clinical Trials - HyperCore - PPDS	Hialeah	Florida
United States	Marshall University Medical Center	Huntington	West Virginia
United States	University of Kentucky	Lexington	Kentucky
United States	Axcess Medical Research	Loxahatchee Groves	Florida
United States	Road Runner Research Ltd	San Antonio	Texas
United States	Ki Health Partners LLC DBA New England Institute for Clinical Research	Stamford	Connecticut
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Italy,  Mexico,  Portugal,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events		Baseline up to Week 44
Secondary	Free Eptinezumab Plasma Concentration		Baseline, Weeks 8, 12, 24, 36, and 44
Secondary	Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])		Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Secondary	Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)		Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Secondary	Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36		Baseline, Weeks 12, 24, and 36