Recruiting
Phase 3

Eptinezumab

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07191145

Conditions

Post Traumatic Headache

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Eptinezumab

Placebo

Study Details

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 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.

Conditions

Post Traumatic Headache

Study ID

NCT07191145

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention - Eptinezumab

Eptinezumab 300mg IV once within 8 weeks of post-traumatic headache onset

placebo comparator: Control - Placebo

Placebo IV once within 8 weeks of post-traumatic headache onset

Interventions

Eptinezumab

Eptinezumab 300mg IV

Placebo

Control - placebo IV

Primary outcome measure

  • Headache frequency [ Time Frame: 9-12 weeks (inclusive) after intervention ]

Central Contacts and Locations

Central contacts

Howard Meng, MD

416-480-4864howard.meng@sunnybrook.ca

Lavarnan Sivanathan, MD

lavarnan.sivanathan@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Howard Meng, MD

416-480-4864howard.meng@sunnybrook.ca

Principal Investigator:

Howar Meng, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Migraine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.