Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
Start Date
7/19/2022
Completion Date
5/19/2027
Summary
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).
Detailed Description
Headache is recognized as one of the most common and disabling symptoms following head trauma. This study is designed to assess a calcitonin gene-related peptide (cGRP) monoclonal antibody (erenumab) for the preventive treatment of PTH based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cGRP. This study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of PTH in military service members and civilians with mTBI at military treatment facilities across the United States.
Eligibility Criteria
Age Range: 18 years to 50 years
Interventions
Erenumab 140 Mg/mL Subcutaneous Solution
Placebo
Conditions
Locations
Womack Army Medical Center - Fort Liberty
Fort Bragg, North Carolina 28310
United States
University of Pittsburgh Concussion Research Laboratory
Pittsburgh, Pennsylvania 15203
United States
William Beaumont Army Medical Center
El Paso, Texas 79918
United States
Madigan Army Medical Center
Tacoma, Washington 98431
United States