Early Eptinezumab for Acute Post-Traumatic Headache

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, placebo-controlled trial investigates whether a single infusion of eptinezumab can prevent the progression of acute post-traumatic headache to a persistent form in patients with a migraine phenotype after mild traumatic brain injury. Participants with acute post-traumatic headache and migraine features, identified within eight weeks of injury, will be assigned to receive either eptinezumab or placebo and monitored for changes in headache burden and persistence. The study uses CGRP-targeted therapy, leveraging prior evidence of CGRP involvement in migraine to address post-traumatic headache. Inclusion requires ICHD-3 defined acute PTH, a migraine screen score, and appropriate female contraception where applicable; key exclusions include moderate-severe TBI and prior CGRP or botulinum toxin treatment. The lead site is Sunnybrook Health Sciences Centre in Toronto, with no other collaborators noted at this time.

Why it matters

Who can join: the full rules

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

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Howard Meng, MD — Sunnybrook Health Sciences Centre
• Study coordinator: Howard Meng, MD
• Email: howard.meng@sunnybrook.ca
• Phone: 416-480-4864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.