NCT05164172 A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
| NCT ID | NCT05164172 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | H. Lundbeck A/S |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2021-12-01 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Email contact via H. Lundbeck A/S
STUDY DIRECTOR
H. Lundbeck A/S
Frequently Asked Questions
Who can join the NCT05164172 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05164172 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT05164172 currently recruiting?
Yes, NCT05164172 is actively recruiting participants. Contact the research team at HQ_Medinfo@Lundbeck.com for enrollment information.
Where is the NCT05164172 trial being conducted?
This trial is being conducted at New Haven, United States, Stamford, United States, Gulf Breeze, United States, Hialeah, United States and 11 additional locations.
Who is sponsoring the NCT05164172 clinical trial?
NCT05164172 is sponsored by H. Lundbeck A/S. The principal investigator is Email contact via H. Lundbeck A/S at H. Lundbeck A/S. The trial plans to enroll 600 participants.
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