NCT07191145RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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 patients with migraines after a single infusion. Patients with PTH have higher serum levels of CGRP and experimental infusion of CGRP to patients with mTBI reproduces migraine PTH symptoms. Given the similarly in CGRP expression between chronic migraines and PTH, an infusion of eptinezumab within 8 weeks of PTH is hypothesized to reduce headache burden 3 months after treatment and prevent pPTH.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 5 Sept 2025
- Start date
- Nov 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Migraine
- NCT number
- NCT07191145
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 80
- From Nov 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of CGRP-related treatment or botulinum toxin within the last three month for migraine
- Concurrent major injuries (long bone, rib, and spinal fractures) or surgical intervention while in hospital on initial trauma
Other illness
- 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)
- Substance / opioids use disorder
- Confounding chronic pain disorder / clinically significant pains
- Uncontrolled psychiatric conditions (depression, PTSD, anxiety, functional neurological disorder)
Other
- Diagnosis of moderate to severe TBI
- On-going litigation for current trauma
- Pregnancy/breast-feeding
- Use of opioids/barbiturates for headaches (\> 4 days/month)
- Hereditary fructose intolerance
Who the study is looking for
- 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.)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.