Actively Recruiting

Phase 2
Age: 18Years - 50Years
All Genders
NCT05049057

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

Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2024-02-22

404

Participants Needed

4

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 50 years
  • Mild traumatic brain injury (mTBI) from any cause within the past 7 days
  • Posttraumatic headache (PTH) started within the past 7 days
  • Able to provide informed consent
  • Likely to remain in the same geographical area for the study duration
  • Has a personal healthcare provider for standard care of PTH and TBI, including education, diagnostic procedures, and treatment as needed
Not Eligible

You will not qualify if you...

  • Sustained moderate or severe traumatic brain injury (TBI) indicated by any of the following:
    1. Abnormal structural imaging
    2. Loss of consciousness for more than 30 minutes
    3. Altered consciousness or mental state for more than 24 hours
    4. Post-traumatic amnesia for more than 1 day
  • Ongoing chronic migraine or other chronic daily headache disorders at the time of injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Womack Army Medical Center - Fort Liberty

Fort Bragg, North Carolina, United States, 28310

Actively Recruiting

2

University of Pittsburgh Concussion Research Laboratory

Pittsburgh, Pennsylvania, United States, 15203

Not Yet Recruiting

3

William Beaumont Army Medical Center

El Paso, Texas, United States, 79918

Actively Recruiting

4

Madigan Army Medical Center

Tacoma, Washington, United States, 98431

Not Yet Recruiting

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Research Team

A

Amy Guthrie, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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