Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury

Stopped early · Phase 2

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT05970575

Run by

Neurological Associates of West Los Angeles

People needed

4

Starts

2023-12-21

Expected to finish

2025-07-21

Last updated by the study team

2025-07-25

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Regenesis Project — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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