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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Eptinezumab for Post Traumatic Headache

Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH.

Official registry: https://clinicaltrials.gov/study/NCT07191145 · Sunnybrook Health Sciences Centre · enrollment listed as 80

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. Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH).

They plan to enroll about 80 people at Toronto. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

Interventions: Eptinezumab, Placebo

Primary outcome (registry wording): Headache frequency

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Meet diagnostic criteria for acute post-traumatic headache as per ICHD-3 criteria
  • Meet migraine screening questionnaire criteria (MSQ score ≥ 4) during at least one of the weekly screening calls
  • Within 8 weeks after onset of PTH
  • \* Imaging is not required for inclusion

Public study contact (from the registry)

Howard Meng, MD

416-480-4864

howard.meng@sunnybrook.ca

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

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07191145 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 NCT07191145?

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 NCT07191145?

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