Status:
TERMINATED
Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury
Lead Sponsor:
Neurological Associates of West Los Angeles
Collaborating Sponsors:
BioVie Inc.
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
This study seeks to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of Traumatic Brain Injury and inflammatory and metabolic parameters.
Detailed Description
A growing body of literature recognizes neuroinflammation as a pivotal contributor to the pathogenesis of TBI. A surge of inflammatory cytokines and chemokines, including tumor necrosis factor-alpha (...
Eligibility Criteria
Inclusion
- Diagnosis of traumatic brain injury, confirmed by neurologist or other medical professional
- Age within range of 18-75 years old
- Multidimensional Fatigue Inventory (MFI) score of 27 or greater
- Epworth Sleepiness Scale (ESS) score of 10 or greater AND/OR a Pittsburgh Sleep Index (PSI) score of 5 or greater
- Ability to Consent: Participants need to be capable of giving informed consent or have a legally authorized representative who can do so.
- Ability to participate for the duration of the study
Exclusion
- In order for a subject to be considered for this study, he/she may NOT have any of the following:
- Diagnosis of other chronic Neurological Conditions: Examples are participants with other pre-existing neurological conditions, such as Alzheimer's or Parkinson's Disease or untreated epilepsy.
- Severe Psychiatric Illness: Conditions such as schizophrenia, bipolar disorder, or severe depression.
- Current diagnosis of Substance Abuse Disorder, including opioid use disorder.
- Dysphagia or Significant GI dysmotility or conditions that would significantly impair absorption
- Significant language impairment with expressive or receptive aphasia
- Hematological or Metabolic derangement or diagnosis of other medical condition that could be negatively affected by participating in this clinical trial.
- Pregnant or plans for pregnancy or breastfeeding during the course of the study
- Diagnosis of genetic or developmental disorder with cognitive impairment
- Use of more than 2 sleep aids including melatonin
- Advanced stages of any terminal illness or any active cancer that requires chemotherapy
- History of breast cancer
- Women with child-bearing potential who are not willing to use a double-barrier birth control method
- Males not willing to use a double-barrier birth control method with female sex partners with child-bearing potential
- Individuals with hepatic impairment as defined by:
- Alanine aminotransferase (ALT) lab values \>3x the upper normal limit (UNL)
- Aspartate aminotransferase (AST) lab values \>3x UNL
- OR
- History of clinically significant liver disease in the Principal Investigator's medical judgment
- Individuals with renal impairment as defined by Creatinine clearance (Cockcroft-Gault formula) of \<45 mL/min.
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05970575
Start Date
December 21 2023
End Date
July 21 2025
Last Update
July 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Regenesis Project
Santa Monica, California, United States, 90403