RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Eptinezumab for Episodic Migraine

Q: Is NCT05897320 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 NCT05897320?

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 NCT05897320?

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 this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

Official registry: https://clinicaltrials.gov/study/NCT05897320 · H. Lundbeck A/S · enrollment listed as 315

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, or Placebo. The registry lists allocation as randomized. The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.

They plan to enroll about 315 people at 60 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine

Interventions: Eptinezumab, Placebo

Primary outcome (registry wording): Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12

Who it is for (from inclusion criteria)

Ages 6 Years to 17 Years
Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit
During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit
During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary

Who the registry excludes

History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system
Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded
Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance
Other inclusion and

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

60 listed

New England Institute for Clinical Research (NEICR) - Stamford — Stamford, Connecticut (recruiting)
Child Neurology Center (CNC) of Northwest Florida — Gulf Breeze, Florida (recruiting)
AGA Clinical Trials — Hialeah, Florida (recruiting)
University of South Florida (USF) - Tampa Campus — Tampa, Florida (recruiting)
Clinical Integrative Research Center of Atlanta (CIRCAtl) — Atlanta, Georgia (completed)
UK HealthCare-Kentucky Clinic — Lexington, Kentucky (completed)
University of Maryland School of Medicine — Baltimore, Maryland (completed)
Michigan Headache & Neurological Institute (MHNI) — Ann Arbor, Michigan (completed)
True North Neurology - Commack (North Suffolk Neurology) — Commack, New York (completed)
OnSite Clinical Solutions, LLC - Charlotte — Charlotte, North Carolina (completed)
Akron Children's Hospital — Akron, Ohio (recruiting)
Cincinnati Children's Hospital Medical Center-Burnet Campus — Cincinnati, Ohio (recruiting)

+ 45 sites outside the US on the same record

Related recruiting trials in this snapshot

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NCT04649242 · Official ClinicalTrials.gov record · Pfizer

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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

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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 NCT05897320 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 NCT05897320?

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 NCT05897320?

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