Status:
NOT_YET_RECRUITING
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Post Traumatic Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Approximately 500,000 Canadians aged \>12 experienced a mild traumatic brain injury (mTBI) in the preceding year based on a 2020 report. Patients with mTBIs have a cumulative incidence of headaches, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07191145
Start Date
January 1 2026
End Date
September 1 2027
Last Update
December 29 2025
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5