Migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 645 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main goal of the study is to assess the long-term safety of eptinezumab in children and adolescents ages 6 to 17 with chronic or episodic migraine. ;Secondary Objective: Not Applicable;Primary end point(s): 1. Number of Participants With Treatment Emergent Adverse Events ;Timepoint(s) of evaluation of this end point: 1. Time Frame: Baseline up to Week 44 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Free Eptinezumab Plasma Concentration 2. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) 3. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) 4. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36 5. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12 6. Change From Baseline in Monthly Migraine Days Averaged Over Weeks 1-12 7. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12;Timepoint(s) of evaluation of this end point: 1. Time Frame: Baseline, Weeks 8, 12, 24, 36, and 44 2. Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 3. Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 4. Time Frame: Baseline, Weeks 12, 24, and 36 5. Time Frame: Baseline, Weeks 1-12 6. Time Frame: Baseline, Weeks 1-12 7. Time Frame: Baseline, Weeks 1-12 | — |
Countries
Argentina, Canada, Italy, Mexico, Portugal, Serbia, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed