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Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

RecruitingPhase 2

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

Who can join

Ages 18 to 50 · All sexes

Full 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

About the study

This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).

What is being tested

Erenumab 140 Mg/mL Subcutaneous Solution (drug)
Placebo (drug)

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Participants: 404 · Started: Jul 19, 2022

Contact the study team

Amy Guthrie, RN · Phone: 202-924-2729

Official record on ClinicalTrials.gov — NCT05049057

Locations in the U.S.

North Carolina	Womack Army Medical Center - Fort Liberty, Fort Bragg
Pennsylvania	University of Pittsburgh Concussion Research Laboratory, Pittsburgh (Not yet recruiting)
Texas	William Beaumont Army Medical Center, El Paso
Washington	Madigan Army Medical Center, Tacoma (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.