Recruiting
Phase 3

Eptinezumab

Sponsor:

H. Lundbeck A/S

Code:

NCT05164172

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Eptinezumab

Study Details

Brief summary:

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.

Conditions

Migraine

Study ID

NCT05164172

Start date

Dec 1, 2021

Status verified date

Oct, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- 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:

  • The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
  • During lead-in Study19356A or Study19357A:
  • participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
  • the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later.
  • the participant had a serum ALT or AST value >3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eptinezumab 300 mg

Participants will receive 3 intravenous (IV) infusions of eptinezumab 300 mg (weight adjusted) at Weeks 0, 12, and 24.

experimental: Eptinezumab 100 mg

Participants will receive 3 IV infusions of eptinezumab 100 mg (weight adjusted) at Weeks 0, 12, and 24.

Interventions

Eptinezumab

Concentrate for solution for infusion

Primary outcome measure

  • Number of Participants With Treatment Emergent Adverse Events [ Time Frame: Baseline up to Week 44 ]

Central Contacts and Locations

Central contacts

Email contact via H. Lundbeck A/S

+45 36301311HQ_Medinfo@Lundbeck.com

Locations

Yale School of Medicine - The Scirex Clinical Research Unit

Recruiting

New Haven, Connecticut, United States, 06519-1405

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

University of Kentucky (UK) - Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536-0002

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201-1509

True North Neurology - Commack (North Suffolk Neurology)

Recruiting

Commack, New York, United States, 11725-2850

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, 23510

Marshall Health-Marshall University Medical Center

Recruiting

Huntington, West Virginia, United States, 25701-3656

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

Oct 14, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by H. Lundbeck A/S on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.