Recruiting
Phase 3

Eptinezumab

Sponsor:

H. Lundbeck A/S

Code:

NCT04965675

Conditions

Chronic Migraine in Children

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Eptinezumab

Placebo

Study Details

Brief summary:

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Conditions

Chronic Migraine in Children

Study ID

NCT04965675

Start date

Jun 30, 2021

Status verified date

Oct, 2026

Completion date

Mar 26, 2027

Anticipated

Primary completion date

Mar 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
  • During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
  • During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

Exclusion Criteria:

  • The participant has previously been randomised in this study and exposed to eptinezumab.
  • The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.
  • The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.
  • The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes).

Study Design

Enrollment

285 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 IV infusion of eptinezumab 300 mg (weight adjusted).

experimental: Eptinezumab 100 mg

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

placebo comparator: Placebo

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

Interventions

Eptinezumab

Eptinezumab will be administered per dose and schedule specified in the arm.

Placebo

Placebo matching to eptinezumab will be administered per schedule specified in the arm.

Primary outcome measure

  • Change From Baseline in 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

NW FL Clinical Research Group, LLC

Recruiting

Gulf Breeze, Florida, United States, 32561-4495

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012-3407

University of South Florida (USF) - Tampa Campus

Recruiting

Tampa, Florida, United States, 33620

UK HealthCare-Kentucky Clinic

Recruiting

Lexington, Kentucky, United States, 40536

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, 23510-1021

Marshall Health-Marshall University Medical Center

Recruiting

Huntington, West Virginia, United States, 25701-3656

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

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by H. Lundbeck A/S on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.