A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

Phase 3

Recruiting

• Conditions: Episodic Migraine
• Interventions: Drug: Placebo; Drug: Eptinezumab

• Registration Number: NCT05897320
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study Start: 2023-06-08
• Study First Posted: 2023-06-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-19
• Primary Completion: 2027-05-05
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

• Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
• During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
• During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.

Exclusion Criteria

• History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min).
• History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
• Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
• Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.

Other inclusion and exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive a single IV infusion of matching placebo to eptinezumab.
Eptinezumab 100 mg	Eptinezumab	Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).
Eptinezumab 300 mg	Eptinezumab	Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12	Baseline, Weeks 1-12

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Rate of Migraines with Severe Pain Intensity	Baseline, Weeks 1-12
Response: ≥50% Reduction From Baseline in MMDs	Baseline, Weeks 1-4 and Weeks 1-12
Percentage of Participants with Migraine on the Day After Dosing (Day 1)	On Day After Dosing
Change From Baseline in MMDs with Acute Medication Use	Baseline, Weeks 1-12
Change From Baseline in the Number of Monthly Headache Days (MHDs)	Baseline, Weeks 1-12
Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)	Day 0 (pre-dose) and at Weeks 8, 12, and 20
Response: ≥75% reduction from baseline in MMDs	Baseline, Weeks 1-4 and Weeks 1-12
Change From Baseline in Monthly Hours with Headache	Baseline, Weeks 1-12
Free Eptinezumab Plasma Concentrations	Day 0 (pre-dose) and at Weeks 8, 12, and 20
Change From Baseline in Days with Acute Medication	Baseline, Weeks 1-12
Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA])	Day 0 (pre-dose) and at Weeks 8, 12, and 20
Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score	Baseline, Week 12

Trial Locations

Locations (58)

Ki Health Partners LLC DBA New England Institute for Clinical Research; 🇺🇸 Stamford, Connecticut, United States

Child Neurology of NW Florida; 🇺🇸 Gulf Breeze, Florida, United States

A G A Clinical Trials - HyperCore - PPDS; 🇺🇸 Hialeah, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Kentucky HealthCare (UKHC) Kentucky Clinic; 🇺🇸 Lexington, Kentucky, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Michigan Head Pain and Neurological Institute; 🇺🇸 Ann Arbor, Michigan, United States

North Suffolk Neurology-Commack; 🇺🇸 Commack, New York, United States

OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS; 🇺🇸 Charlotte, North Carolina, United States

Childrens Hospital Medical Center of Akron; 🇺🇸 Akron, Ohio, United States

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