Testing Angiotensin (1-7) for treating moderate to severe traumatic brain injury
A Randomized, Double-blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury (TBI)
This study is testing if a new drug called Angiotensin (1-7) can help people with moderate to severe traumatic brain injuries recover better over 21 days.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT06282965 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of Angiotensin (1-7) in individuals who have experienced moderate to severe traumatic brain injury (TBI). Participants will receive daily injections of the drug for 21 days, undergo MRI scans, and complete cognitive assessments to measure improvements in mental functioning and physical signs of brain damage. The study will compare two different doses of Angiotensin (1-7) against a placebo to determine its effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have suffered a moderate to severe TBI within 48 hours of enrollment.
Not a fit: Patients with a history of neurodegenerative diseases or recent neurosurgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve cognitive recovery and overall outcomes for patients with traumatic brain injuries.
How similar studies have performed: While the use of Angiotensin (1-7) in this context is novel, similar studies targeting the renin-angiotensin system have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant or representative willing to provide informed consent. * Age 18 years or older at time of enrollment. * Traumatically induced head injury resulting from insult to head from an external force. * Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan and report must be available. * Moderate or severe traumatic brain injury (TBI) defined as Glasgow Coma Scale (GCS) score on trauma presentation of 12 or less. In general: Moderate TBI will be defined as loss of consciousness between 30 minutes and 24 hours and GCS between 9 and 12. Severe TBI will be defined as loss of consciousness \> 24 hours and GCS ≤ 9. * Enrollment within 48 hours of TBI. Exclusion Criteria: * 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 that would impact cognitive testing. * Contraindication to having an MRI. * Pregnant or lactating female. * Female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug. * Participation in another clinical study involving investigational product within 30 days prior to study enrollment. * If in the opinion of the investigator, candidate is unsuitable for participation in the study.
Where this trial is running
Tucson, Arizona
- University of Arizona — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Bellal Joseph, MD — University of Arizona
- Study coordinator: Clinical Research Coordinator
- Email: traumaresearch@arizona.edu
- Phone: (520) 237-6845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.