Actively Recruiting
Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury
Led by University of Arizona · Updated on 2025-07-31
90
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
Sponsors
U
University of Arizona
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI). The main questions this trial aims to answer are: * Is Angiotensin (1-7) safe? * Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI? Participants will: * Complete 21 days of study treatment consisting of a once-daily injection. * Provide blood samples. * Undergo two magnetic resonance imaging (MRI) scans of the brain. * Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning. Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI.
CONDITIONS
Official Title
Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or representative willing to provide informed consent
- Age 18 years or older at time of enrollment
- Traumatically induced head injury from external force
- Clinical diagnosis of acute intracranial lesion based on neuroradiologist report with available CT scan
- Moderate or severe traumatic brain injury defined by Glasgow Coma Scale score of 12 or less
- Enrollment within 48 hours of traumatic brain injury
You will not qualify if you...
- Time of injury cannot be determined
- Neurosurgery within the last 30 days
- History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors affecting cognitive testing
- Contraindication to having an MRI
- Pregnant or lactating female
- Female of childbearing potential or sexually active male unwilling to use birth control during treatment and 7 days after last dose
- Participation in another investigational study within 30 days prior to enrollment
- Considered unsuitable for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
C
Clinical Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here