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

Mild Traumatic Brain Injury Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Headache
• Mild Traumatic Brain Injury
• Post-Traumatic Headache
• Posttraumatic Headache

• NCT number: NCT05049057
• Study type: Interventional
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: Amy Guthrie, RN
• Phone: 202-924-2729
• Email: amy.guthrie.ctr@usuhs.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: July 19, 2022
• Completion date: May 19, 2027