RECRUITING

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

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Conditions

Posttraumatic HeadacheMild Traumatic Brain Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2022-07-19
Study Completion:2027-05-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05049057

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥18 and ≤50 years of age
  2. * mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
  3. * PTH has occurred within the prior 7 days
  4. * Able to provide informed consent
  5. * Likely to stay in the same geographical area for the duration of study
  6. * 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
  1. * Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:
  2. 1. abnormal structural imaging
  3. 2. loss of consciousness for \>30 minutes
  4. 3. alteration of consciousness/mental state for \>24 hours 3. post-traumatic amnesia for \>1 day
  5. * Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury

Contacts and Locations

Study Contact

Amy Guthrie, RN
CONTACT
202-924-2729
amy.guthrie.ctr@usuhs.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-19
Study Completion Date2027-05-19

Study Record Updates

Study Start Date2022-07-19
Study Completion Date2027-05-19

Terms related to this study

Additional Relevant MeSH Terms

  • Posttraumatic Headache
  • Mild Traumatic Brain Injury