RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Eptinezumab for Migraine

Q: Is NCT05164172 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT05164172?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05164172?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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.

Official registry: https://clinicaltrials.gov/study/NCT05164172 · H. Lundbeck A/S · enrollment listed as 600

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Eptinezumab. The registry lists allocation as randomized. 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.

They plan to enroll about 600 people at 64 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

Interventions: Eptinezumab

Primary outcome (registry wording): Number of Participants With Treatment Emergent Adverse Events

Who it is for (from inclusion criteria)

Ages 6 Years to 17 Years
\- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study

Who the registry excludes

The participant has an adverse event or other safety concerns that are deemed related to neither you nor the study doctors know who gets the real treatment 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

Public study contact (from the registry)

Email contact via H. Lundbeck A/S

+45 36301311

HQ_Medinfo@Lundbeck.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

64 listed

Yale School of Medicine - The Scirex Clinical Research Unit — New Haven, Connecticut (recruiting)
New England Institute for Clinical Research (NEICR) - Stamford — Stamford, Connecticut (recruiting)
Sarkis Clinical Trials - Gainsville — Gainesville, Florida (completed)
NW FL Clinical Research Group, LLC — Gulf Breeze, Florida (recruiting)
AGA Clinical Trials — Hialeah, Florida (recruiting)
Axcess Medical Research - Loxahatchee — Loxahatchee Groves, Florida (completed)
University of South Florida (USF) - Tampa Campus — Tampa, Florida (recruiting)
University of Kentucky (UK) - Markey Cancer Center — Lexington, Kentucky (recruiting)
University of Maryland School of Medicine — Baltimore, Maryland (recruiting)
Michigan Headache & Neurological Institute (MHNI) — Ann Arbor, Michigan (completed)
Corewell Health - Helen DeVos Children's Hospital (HDVCH) - Medical Genetics — Grand Rapids, Michigan (completed)
Dent Neurosciences Research Center — Amherst, New York (completed)

+ 44 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingPhase 3Birmingham, Alabama

Phase 3: testing Rimegepant/BHV3000 for Pediatric Migraine

This study wants to test the safety and how well it works of BHV-3000 versus dummy treatment (placebo) in the acute treatment of moderate or severe migraine in children and adolescents.

NCT04649242 · Official ClinicalTrials.gov record · Pfizer

RecruitingPhase 3Scottsdale, Arizona

Phase 3: testing Rimegepant (PF-07899801) for Acute Treatment of Migraine

This study wants to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).

NCT04743141 · Official ClinicalTrials.gov record · Pfizer

RecruitingPhase 3New Haven, Connecticut

Phase 3: testing Eptinezumab for Chronic Migraine in Children

To find out if eptinezumab is better than dummy treatment (placebo) (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

NCT04965675 · Official ClinicalTrials.gov record · H. Lundbeck A/S

FAQ about this NCT record

Is NCT05164172 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05164172?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05164172?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary