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.
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
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.)
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