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

Jun, 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 University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06511

Ki Health Partners LLC DBA New England Institute for Clinical Research

Recruiting

Stamford, Connecticut, United States, 06905-1206

NW FL Clinical Research Group, LLC

Recruiting

Gulf Breeze, Florida, United States, 32561-4458

AGA Clinical Trials - Hialeah - 4980 W 10th Ave

Recruiting

Hialeah, Florida, United States, 33012

University of South Florida

Recruiting

Tampa, Florida, United States, 33612-6601

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536-7001

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201-1544

True North Neurology

Recruiting

Commack, New York, United States, 11725-2808

Childrens Hospital Medical Center of Akron

Recruiting

Akron, Ohio, United States, 44308-1063

Cincinnati Children's Hospital Medical Center - PIN

Recruiting

Cincinnati, Ohio, United States, 45229-3026

Road Runner Research Ltd

Recruiting

San Antonio, Texas, United States, 78249-3539

Children's Specialty Group - 3 Commercial Place

Recruiting

Norfolk, Virginia, United States, 23510

Marshall University Medical Center

Recruiting

Huntington, West Virginia, United States, 25701-3656

Children's Wisconsin - Milwaukee Campus - PIN

Recruiting

Milwaukee, Wisconsin, United States, 53226

Vancouver Island Health Authority

Recruiting

Victoria, British Columbia, Canada, V8R 1J8

The Kids Clinic

Recruiting

Ajax, Ontario, Canada, L1Z 0M1

London Health Sciences Centre -800 Commissioners Rd E

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

H. Lundbeck A/S

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by H. Lundbeck A/S on 2026-06-12.