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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Womack Army Medical Center - Fort Liberty
  Fort Bragg, North Carolina, United States Recruiting
• William Beaumont Army Medical Center
  El Paso, Texas, United States Recruiting
• University of Pittsburgh Concussion Research Laboratory
  Pittsburgh, Pennsylvania, United States Not yet 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
• Email: amy.guthrie.ctr@usuhs.edu
• Phone: 202-924-2729

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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.