Recruiting
Phase 3

Eptinezumab

Sponsor:

H. Lundbeck A/S

Code:

NCT05897320

Conditions

Episodic Migraine

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Eptinezumab

Placebo

Study Details

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.

Conditions

Episodic Migraine

Study ID

NCT05897320

Start date

Jun 8, 2023

Status verified date

Sep, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jul 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Enrollment

315 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eptinezumab 300 mg

Participants will receive a single intravenous (IV) infusion of eptinezumab 300 mg (weight adjusted).

placebo comparator: Placebo

Participants will receive a single IV infusion of matching placebo to eptinezumab.

experimental: Eptinezumab 100 mg

Participants will receive a single IV infusion of eptinezumab 100 mg (weight adjusted).

Interventions

Eptinezumab

Solution for infusion

Placebo

Solution for infusion

Primary outcome measure

  • Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 [ Time Frame: Baseline, Weeks 1-12 ]

Central Contacts and Locations

Central contacts

Email contact via H. Lundbeck A/S

+45 36301311HQ_Medinfo@Lundbeck.com

Locations

New England Institute for Clinical Research (NEICR) - Stamford

Recruiting

Stamford, Connecticut, United States, 06905-1206

Child Neurology Center (CNC) of Northwest Florida

Recruiting

Gulf Breeze, Florida, United States, 32561-4458

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012-3407

University of South Florida (USF) - Tampa Campus

Recruiting

Tampa, Florida, United States, 33620

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308-1062

Cincinnati Children's Hospital Medical Center-Burnet Campus

Recruiting

Cincinnati, Ohio, United States, 45229-3026

Road Runner Research (RRR)

Recruiting

San Antonio, Texas, United States, 78249-3539

Children's Specialty Group (CSG)

Recruiting

Norfolk, Virginia, United States, 23507

Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus

Recruiting

Milwaukee, Wisconsin, United States, 53226

Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic

Recruiting

Victoria, British Columbia, Canada, V8R 1J8

Kids Clinic

Recruiting

Ajax, Ontario, Canada, L1Z 0M1

London Health Sciences Centre (LHSC)

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

H. Lundbeck A/S

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by H. Lundbeck A/S on 2026-09-09.