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Tests treatment safety and results for Traumatic Brain Injury
Official title Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury
ClinicalTrials.gov ID: NCT06282965
What this study is testing
What is Angiotensin (1-7)?
Angiotensin (1-7) is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for traumatic brain injury.
Also referred to as Angiotensin I/II (1-7) acetate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- Enrollment within 48 hours of TBI.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.