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

Description

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).

Conditions

Posttraumatic Headache, Mild Traumatic Brain Injury

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Posttraumatic Headache
Intervention / Treatment

-

Contacts and Locations

Fort Bragg

Womack Army Medical Center - Fort Liberty, Fort Bragg, North Carolina, United States, 28310

Pittsburgh

University of Pittsburgh Concussion Research Laboratory, Pittsburgh, Pennsylvania, United States, 15203

El Paso

William Beaumont Army Medical Center, El Paso, Texas, United States, 79918

Tacoma

Madigan Army Medical Center, Tacoma, Washington, United States, 98431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Henry M. Jackson Foundation for the Advancement of Military Medicine,

David L Brody, MD, PhD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

Study Record Dates

2027-05-19