A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine (REJOIN)
Primary Purpose
Migraine
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eptinezumab
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
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.
Sites / Locations
- Ki Health Partners LLC DBA New England Institute for Clinical ResearchRecruiting
- NW FL Clinical Research Group, LLCRecruiting
- A G A Clinical Trials - HyperCore - PPDSRecruiting
- Axcess Medical ResearchRecruiting
- University of South FloridaRecruiting
- University of Maryland School of MedicineRecruiting
- Michigan Head Pain and Neurological InstituteRecruiting
- Michigan State University - Department of NeurologyRecruiting
- Dent Neurosciences Research Center IncorporatedRecruiting
- OnSite Clinical Solutions, LLC - Charlotte - ClinEdge - PPDSRecruiting
- Hospital Privado de La ComunidadRecruiting
- Expertia S.A- Mautalen Salud e InvestigacionRecruiting
- Hospital de Niños de La Santisima TrinidadRecruiting
- Centro de Investigaciones Médicas TucumanRecruiting
- The Kids ClinicRecruiting
- Ospedale San Raffaele S.r.l. - INCIPIT - PINRecruiting
- Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3Recruiting
- AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PINRecruiting
- Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PINRecruiting
- Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.Recruiting
- Clinical Research InstituteRecruiting
- Instituto de Investigationes Clinicas para la Salud A.C.Recruiting
- Children and Youth Health Care Institute of VojvodinaRecruiting
- Hospital Universitario Vall d'Hebron - PPDSRecruiting
- Hospital Universitario Virgen del Rocio - PPDSRecruiting
- Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
- Queen Elizabeth University Hospital - PPDSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Eptinezumab 300 mg
Eptinezumab 100 mg
Arm Description
Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events
Secondary Outcome Measures
Free Eptinezumab Plasma Concentration
Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05164172
Brief Title
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
Acronym
REJOIN
Official Title
Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eptinezumab 300 mg
Arm Type
Experimental
Arm Description
Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
Arm Title
Eptinezumab 100 mg
Arm Type
Experimental
Arm Description
Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Other Intervention Name(s)
Vyepti
Intervention Description
Concentrate for solution for infusion
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events
Time Frame
Baseline up to Week 44
Secondary Outcome Measure Information:
Title
Free Eptinezumab Plasma Concentration
Time Frame
Baseline, Weeks 8, 12, 24, 36, and 44
Title
Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Time Frame
Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Title
Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
Time Frame
Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Title
Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36
Time Frame
Baseline, Weeks 12, 24, and 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Email contact via H. Lundbeck A/S
Phone
+45 36301311
Email
LundbeckClinicalTrials@Lundbeck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
H. Lundbeck A/S
Official's Role
Study Director
Facility Information:
Facility Name
Ki Health Partners LLC DBA New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905-1206
Country
United States
Individual Site Status
Recruiting
Facility Name
NW FL Clinical Research Group, LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561-4458
Country
United States
Individual Site Status
Recruiting
Facility Name
A G A Clinical Trials - HyperCore - PPDS
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-3402
Country
United States
Individual Site Status
Recruiting
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470-9272
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-6601
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-5131
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan State University - Department of Neurology
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824-7015
Country
United States
Individual Site Status
Recruiting
Facility Name
Dent Neurosciences Research Center Incorporated
City
Amherst
State/Province
New York
ZIP/Postal Code
14226-1727
Country
United States
Individual Site Status
Recruiting
Facility Name
OnSite Clinical Solutions, LLC - Charlotte - ClinEdge - PPDS
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211-5027
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Privado de La Comunidad
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7603
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Expertia S.A- Mautalen Salud e Investigacion
City
Ciudad Autonoma de Buenos Aires
State/Province
Ciudad Autonoma De BuenosAires
ZIP/Postal Code
C1128AAF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital de Niños de La Santisima Trinidad
City
Cordoba-Barrio Crisol
State/Province
Cordoba
ZIP/Postal Code
X5014AKM
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Médicas Tucuman
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
The Kids Clinic
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1Z 0M1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele S.r.l. - INCIPIT - PIN
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - INCIPIT - PIN
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Medico Biologica y de Terapia Avanzada S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute
City
Ampl San Lucas Tepetlacalco
State/Province
México
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto de Investigationes Clinicas para la Salud A.C.
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Children and Youth Health Care Institute of Vojvodina
City
Novi Sad
ZIP/Postal Code
21 000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth University Hospital - PPDS
City
Glasgow
ZIP/Postal Code
G514TF
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
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