Using a medication to treat headaches after mild brain injuries in military and civilian patients

Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension

This study is testing if a new medication can help people with mild brain injuries and headaches feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 404 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine (Academic / other)
• Drugs / interventions: erenumab
• Locations: 4 sites (Fort Bragg, North Carolina and 3 other locations)
• Trial ID: NCT05049057 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of erenumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP), for treating acute posttraumatic headache (PTH) in individuals with mild traumatic brain injury (mTBI). It is a randomized, double-blind, placebo-controlled trial conducted at military treatment facilities across the United States. Participants will receive either erenumab or a placebo to determine the medication's impact on headache relief and overall safety. The study focuses on individuals who have experienced mTBI and PTH within the last week.

Who should consider this trial

Good fit: Ideal candidates are military service members and civilians aged 18 to 50 who have experienced mild traumatic brain injury and posttraumatic headache within the past week.

Not a fit: Patients with moderate or severe traumatic brain injuries or chronic headache disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate headache symptoms in patients suffering from posttraumatic headaches following mild traumatic brain injuries.

How similar studies have performed: Other studies have shown promising results with CGRP inhibitors for migraine treatment, suggesting potential success for this novel application in posttraumatic headache.

Eligibility criteria

Inclusion Criteria:

* Male or female ≥18 and ≤50 years of age
* mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
* PTH has occurred within the prior 7 days
* Able to provide informed consent
* Likely to stay in the same geographical area for the duration of study
* Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider

Exclusion Criteria:

* Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:

  1. abnormal structural imaging
  2. loss of consciousness for \>30 minutes
  3. alteration of consciousness/mental state for \>24 hours 3. post-traumatic amnesia for \>1 day
* Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury

Where this trial is running

Fort Bragg, North Carolina and 3 other locations

• Womack Army Medical Center - Fort Liberty — Fort Bragg, North Carolina, United States (Recruiting)
• University of Pittsburgh Concussion Research Laboratory — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
• William Beaumont Army Medical Center — El Paso, Texas, United States (Recruiting)
• Madigan Army Medical Center — Tacoma, Washington, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: David L Brody, MD, PhD — Uniformed Services University of the Health Sciences
• Study coordinator: Amy Guthrie, RN

Conditions Posttraumatic Headache; Mild Traumatic Brain Injury