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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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