Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Posttraumatic Headache, Mild Traumatic Brain Injury
In brief
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).
Key facts
- Study ID
- NCT05049057
- Run by
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- People needed
- 404
- Starts
- 2022-07-19
- Expected to finish
- 2027-05-19
- Last updated by the study team
- 2024-02-22
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:
- abnormal structural imaging
- loss of consciousness for >30 minutes
- 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
Where it is running
- Womack Army Medical Center - Fort Liberty — Fort Bragg, North Carolina, United States (enrolling)
- William Beaumont Army Medical Center — El Paso, Texas, United States (enrolling)
- University of Pittsburgh Concussion Research Laboratory — Pittsburgh, Pennsylvania, United States
- Madigan Army Medical Center — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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