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PlainTrials
RecruitingPhase 3interventionalRules rewrite

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.

Official registry: https://clinicaltrials.gov/study/NCT04965675 · H. Lundbeck A/S · enrollment listed as 285

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. 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.

They plan to enroll about 285 people at 76 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

Interventions: Eptinezumab, Placebo

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

Who it is for (from inclusion criteria)

  • Ages 12 Years to 17 Years
  • The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit
  • During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit
  • During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary

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

76 listed

+ 54 sites outside the US on the same record

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT04965675 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 NCT04965675?

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 NCT04965675?

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

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