RecruitingPhase 3NCT05164172
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine
Sponsor
H. Lundbeck A/S
Enrollment
600 participants
Start Date
Dec 1, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 6 YearsMax Age: 17 Years
Inclusion Criteria1
- \- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.
Exclusion Criteria5
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGEptinezumab
Concentrate for solution for infusion
Locations(69)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05164172
Related Trials
Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
NCT0697205623 locations
Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine
NCT06241313149 locations
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
NCT0515639890 locations
Mind Body Balance for Pediatric Migraine
NCT047156852 locations
MMA Embolization for Refractory Chronic Migraine
NCT067358337 locations