A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

Recruiting now · Phase 3

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT05164172

Run by

H. Lundbeck A/S

People needed

600

Starts

2021-12-01

Expected to finish

2028-04-30

Last updated by the study team

2026-06-12

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study.

You may not qualify if…

• 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.

Where it is running

• IRCCS Ospedale Pediatrico Bambino Gesu — Rome, Lazio, Italy (enrolling)
• Ospedale San Raffaele S.r.l. — Milan, Lombardy, Italy (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• London Health Sciences Centre -800 Commissioners Rd E — London, Ontario, Canada (enrolling)
• NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States (enrolling)
• IRCCS Istituto Giannina Gaslini — Genoa, Liguria, Italy (enrolling)
• University of Maryland School of Medicine — Baltimore, Maryland, United States (enrolling)
• AGA Clinical Trials - Hialeah - 4980 W 10th Ave — Hialeah, Florida, United States (enrolling)
• Vancouver Island Health Authority — Victoria, British Columbia, Canada (enrolling)
• The Kids Clinic — Ajax, Ontario, Canada (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• True North Neurology — Commack, New York, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• Childrens Hospital Medical Center of Akron — Akron, Ohio, United States (enrolling)
• Cincinnati Children's Hospital Medical Center - PIN — Cincinnati, Ohio, United States (enrolling)
• Road Runner Research Ltd — San Antonio, Texas, United States (enrolling)
• Children's Specialty Group - 3 Commercial Place — Norfolk, Virginia, United States (enrolling)
• Marshall University Medical Center — Huntington, West Virginia, United States (enrolling)
• Children's Wisconsin - Milwaukee Campus - PIN — Milwaukee, Wisconsin, United States (enrolling)
• Ki Health Partners LLC DBA New England Institute for Clinical Research — Stamford, Connecticut, United States (enrolling)
• Hospital de Niños de La Santisima Trinidad — Córdoba-Barrio Crisol, Córdoba Province, Argentina (enrolling)
• Instituto Médico Río Cuarto — Río Cuarto, Córdoba Province, Argentina (enrolling)
• INECO Neurociencias Oroño — Rosario, Santa Fe Province, Argentina (enrolling)
• Centro de Investigaciones Médicas Tucumán - PPDS — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• AO Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza — Cagliari, Sardinia, Italy (enrolling)

Full record on ClinicalTrials.gov

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