A Phase 3 interventional study of Eptinezumab in Migraine, sponsored by H. Lundbeck A/S. Recruiting at 70 sites in 11 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 600 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
- 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:
Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.
Drug: Eptinezumab
Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.
Drug: Eptinezumab
Concentrate for solution for infusion
Also known as: Vyepti
Number of Participants With Treatment Emergent Adverse Events
Time frame: Baseline up to Week 44
Free Eptinezumab Plasma Concentration
Time frame: Baseline, Weeks 8, 12, 24, 36, and 44
Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Time frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
Time frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44
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
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H. Lundbeck A/S