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

NCT05970575 | Terminated Phase 2 FDA Drug

• 1 other identifier: NE3107-TBI-TRP
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

• Safety as Assessed by Quantification of Adverse Events

  Primary outcome will be collection of AEs and SAEs

  up to 6 months

• Pittsburgh Sleep Quality Index (PSQI)

  a tool used to measure the quality and patterns of sleep

  Baseline, 3 months, 6 months

• Multidimensional Fatigue Inventory (MFI)

  to measure overall fatigue

  Baseline, 3 Months, 6 Months

Secondary Outcomes (1)

• Montreal Objective Cognitive Assessment change

  Baseline, 3 Months, 6 Months

Study Arms (1)

Experimental Arm: NE3107

EXPERIMENTAL

All participants will take 200mg BID (12 hours apart) of NE3107 for 6 months.

Drug: NE3107

Interventions

NE3107 DRUG

Participants will take 20mg twice daily (BID) approximately 12 hours apart. The dose will be stable the duration of the study intervention (6 months)

Experimental Arm: NE3107

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead
• BioVie Inc.: collaborator

Study Sites (1)

The Regenesis Project

Santa Monica, California, 90403, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: December 21, 2023
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)