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Insulin Sensitizer

NE3107 for Traumatic Brain Injury

Phase 2
Recruiting
Research Sponsored by Neurological Associates of West Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age within range of 18-75 years old
Diagnosis of traumatic brain injury, confirmed by neurologist or other medical professional
Must not have
Women with child-bearing potential who are not willing to use a double-barrier birth control method
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to measure changes in thinking abilities using tests involving words and pictures, as well as changes in certain markers related to brain injury and inflammation.

Who is the study for?
This trial is for adults aged 18-75 with traumatic brain injury confirmed by a medical professional. Participants must experience significant fatigue or sleepiness, as indicated by specific scores on the MFI and ESS or PSI scales. They need to be able to consent themselves or have someone who can consent for them, and commit to the study duration.
What is being tested?
The trial is testing NE3107, focusing on its effects on improving cognition through verbal and visual tests, as well as assessing changes in biomarkers related to traumatic brain injury and various inflammatory and metabolic parameters.
What are the potential side effects?
The summary did not provide specific side effects of NE3107; however, common side effects in trials like this may include gastrointestinal issues, headaches, dizziness, potential allergic reactions or other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have been diagnosed with a traumatic brain injury by a medical professional.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing to use two forms of birth control.
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My liver function tests are high, or I have a significant liver disease.
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I have swallowing difficulties or severe digestive issues.
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I have a genetic condition that affects my thinking or learning.
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I have an advanced terminal illness or cancer needing chemotherapy.
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I have had breast cancer in the past.
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I am a male and unwilling to use double-barrier contraception.
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My kidney function is reduced with a creatinine clearance below 45 mL/min.
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I use more than two sleep aids, including melatonin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Multidimensional Fatigue Inventory (MFI)
Pittsburgh Sleep Quality Index (PSQI)
Safety as Assessed by Quantification of Adverse Events
Secondary study objectives
Montreal Objective Cognitive Assessment change

Side effects data

From 2022 Phase 2 trial • 23 Patients • NCT05227820
4%
Dizziness
4%
Diarrhea
4%
Tachycardia
4%
COVID-19 Infection
4%
Elevated Lipase
4%
Urinary Tract Infection
4%
Knee Injury
4%
Dry Mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental Arm: NE3107

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental Arm: NE3107Experimental Treatment1 Intervention
All participants will take 200mg BID (12 hours apart) of NE3107 for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NE3107
2021
Completed Phase 3
~510

Find a Location

Who is running the clinical trial?

BioVie Inc.Industry Sponsor
5 Previous Clinical Trials
529 Total Patients Enrolled
Neurological Associates of West Los AngelesLead Sponsor
25 Previous Clinical Trials
3,955 Total Patients Enrolled
~0 spots leftby Dec 2024
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