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Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)

RecruitingPhase 3Ages 18 Years - 65 YearsAllSunnybrook Health Sciences Centre
NCT07191145 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Patients with migraine-PTH are at greater risk of persistent symptoms whereby the acute PTH (aPTH) becomes persistent PTH (pPTH) (ie. lasting \> 3 months) with a conversion rate of 47-95%. As migraine symptoms become chronic, it becomes treatment resistant. Despite these implications, early preventive medication management of PTH is marred by lengthy trials of multiple medications (2-3 months for each) and adverse effects that aggravate mTBI symptoms (fatigue, nausea, and presyncope). There is a compelling need to establish an effective treatment to prevent this debilitating outcome. Eptinezumab is a calcitonin gene-related peptide (CGRP)-blocking monoclonal antibody that reduces migraine burden in patie

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Negative human chorionic gonadotropin test before treatment, for female participants of childbearing potential who are not practicing medically appropriate methods of birth control (e.g., hormonal contraceptives, implants, injectables, intrauterine devices, intrauterine systems, etc.) Exclusion Criteria: * Diagnosis of moderate to severe TBI * History of mTBI within the past 5 years * Pre-existing chronic migraine and its subtypes, tension-type headache, trigeminal autonomic cephalalgias, cranial neuralgias, daily headache, diagnosis of another secondary headache disorder per ICHD-3 (except medication overuse headache) * Concurrent use of CGRP-related treatment or botulinum toxin within the last three month for migraine * Substance / opioids use disorder * Confounding chronic pain disorder / clinically significant pains * Concurrent major injuries (long bone, rib, and spinal fractures) or surgical intervention while in hospital on initial trauma * On-going litigation for current trauma * Pregnancy/breast-feeding * Uncontrolled psychiatric conditions (depression, PTSD, anxiety, functional neurological disorder) * Use of opioids/barbiturates for headaches (\> 4 days/month) * Hereditary fructose intolerance
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What it tests

  • Eptinezumab
  • Placebo
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Where

1 site
Sunnybrook Health Sciences Centre
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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