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RecruitingPhase 3

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

H. Lundbeck A/S · NCT05164172

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
600
US sites recruiting
14
Study start
December 1, 2021
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Eptinezumab

Conditions: Migraine

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Yale School of Medicine - The Scirex Clinical Research Unit

    New Haven, CT 06519-1405

  • New England Institute for Clinical Research (NEICR) - Stamford

    Stamford, CT 06905-1206

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, FL 32561-4495

  • AGA Clinical Trials

    Hialeah, FL 33012-3407

  • University of South Florida (USF) - Tampa Campus

    Tampa, FL 33620

  • University of Kentucky (UK) - Markey Cancer Center

    Lexington, KY 40536-0002

  • University of Maryland School of Medicine

    Baltimore, MD 21201-1509

  • True North Neurology - Commack (North Suffolk Neurology)

    Commack, NY 11725-2850

  • Akron Children's Hospital

    Akron, OH 44308-1062

  • Cincinnati Children's Hospital Medical Center-Burnet Campus

    Cincinnati, OH 45229-3026

  • Road Runner Research (RRR)

    San Antonio, TX 78249-3539

  • Children's Specialty Group (CSG)

    Norfolk, VA 23510

  • Marshall Health-Marshall University Medical Center

    Huntington, WV 25701-3656

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

    Milwaukee, WI 53226

Study contacts (from the official record)

  • Email contact via H. Lundbeck A/S · +45 36301311 · HQ_Medinfo@Lundbeck.com
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A Study With Eptinezumab in Children and Adolescents (6 to 17… (NCT05164172) | Bored Studies