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โ† Trials
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Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllUniversity of Arizona
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In plain words

What the trial is, and whether it could suit you

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-a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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.
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What it tests

  • Angiotensin (1-7)
  • Sterile saline
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Where

1 site
University of Arizona
Tucson, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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