A Phase 3 interventional study of Eptinezumab and Placebo in Episodic Migraine, sponsored by H. Lundbeck A/S. Recruiting at 60 sites in 11 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 315 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 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.
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Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).
Drug: Eptinezumab
Participants will receive a single IV infusion of matching placebo to eptinezumab.
Drug: Placebo
Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Drug: Eptinezumab
Solution for infusion
Solution for infusion
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Time frame: Baseline, Weeks 1-12
Response: ≥50% Reduction From Baseline in MMDs
Time frame: Baseline, Weeks 1-4 and Weeks 1-12
Percentage of Participants with Migraine on the Day After Dosing (Day 1)
Time frame: On Day After Dosing
Change From Baseline in MMDs with Acute Medication Use
Time frame: Baseline, Weeks 1-12
Response: ≥75% reduction from baseline in MMDs
Time frame: Baseline, Weeks 1-4 and Weeks 1-12
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Time frame: Baseline, Weeks 1-12
Change From Baseline in Monthly Hours with Headache
Time frame: Baseline, Weeks 1-12
Change From Baseline in Days with Acute Medication
Time frame: Baseline, Weeks 1-12
Change From Baseline in Rate of Migraines with Severe Pain Intensity
Time frame: Baseline, Weeks 1-12
Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score
Time frame: Baseline, Week 12
Free Eptinezumab Plasma Concentrations
Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)
Time frame: Day 0 (pre-dose) and at Weeks 8, 12, and 20
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Started Jun 2023 (actual). Primary completion is estimated for Jul 2027, 48 months after the start.
Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 48 months is above that.
Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Eptinezumab