NE3107 for Traumatic Brain Injury
KM
JH
Overseen ByJonathan Haroon
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Neurological Associates of West Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the drug NE3107 different from other treatments for traumatic brain injury?
What is the purpose of this trial?
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.
Eligibility Criteria
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.Inclusion Criteria
Multidimensional Fatigue Inventory (MFI) score of 27 or greater
I can commit to the full length of the study.
Epworth Sleepiness Scale (ESS) score of 10 or greater AND/OR a Pittsburgh Sleep Index (PSI) score of 5 or greater
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Exclusion Criteria
I am not willing to use two forms of birth control.
My liver function tests are high, or I have a significant liver disease.
Significant language impairment with expressive or receptive aphasia
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 200mg BID of NE3107 for 6 months to evaluate its effects on sleep and fatigue in TBI subjects
6 months
Visits at Baseline, 3 months, and 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- NE3107
Trial Overview 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.
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurological Associates of West Los Angeles
Lead Sponsor
Trials
26
Recruited
4,000+
BioVie Inc.
Industry Sponsor
Trials
8
Recruited
800+
Findings from Research
In a study using male Wistar rats with mild traumatic brain injury (TBI), treatment with the hybrid molecule JM-20 significantly improved locomotor and exploratory activities, as well as short-term memory deficits, indicating its potential efficacy in TBI recovery.
JM-20 also demonstrated a neuroprotective effect by reducing brain edema and attenuating neuroinflammation, as it prevented the excessive activation of glial cells and restored levels of important neurotrophic factors like BDNF, GDNF, and NGF.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
JM-20 Treatment After Mild Traumatic Brain Injury Reduces Glial Cell Pro-inflammatory Signaling and Behavioral and Cognitive Deficits by Increasing Neurotrophin Expression.Furtado, ABV., Gonรงalves, DF., Hartmann, DD., et al.[2022]
NNZ-2566, a tripeptide analogue, shows neuroprotective effects in traumatic brain injury models by significantly reducing inflammatory cytokines and enhancing the expression of the protective protein ATF3 in various cell types.
The treatment with NNZ-2566 not only increases ATF3 mRNA levels but also boosts protein expression in microglia, NK cells, and astrocytes, suggesting a mechanism by which it modulates neuroinflammation and promotes recovery after brain injury.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Mechanism of action for NNZ-2566 anti-inflammatory effects following PBBI involves upregulation of immunomodulator ATF3.Cartagena, CM., Phillips, KL., Williams, GL., et al.[2021]
Memantine, a non-competitive NMDA receptor antagonist, was found to significantly prevent neuronal death in the hippocampal CA2 and CA3 regions of adult rats after traumatic brain injury, with reductions in cell loss of 50% and 59%, respectively.
This study is the first to demonstrate the neuroprotective effects of memantine following traumatic brain injury, suggesting its potential as a treatment to mitigate neuronal damage.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Neuroprotection by memantine, a non-competitive NMDA receptor antagonist after traumatic brain injury in rats.Rao, VL., Dogan, A., Todd, KG., et al.[2019]
References
JM-20 Treatment After Mild Traumatic Brain Injury Reduces Glial Cell Pro-inflammatory Signaling and Behavioral and Cognitive Deficits by Increasing Neurotrophin Expression. [2022]
Mechanism of action for NNZ-2566 anti-inflammatory effects following PBBI involves upregulation of immunomodulator ATF3. [2021]
Neuroprotection by memantine, a non-competitive NMDA receptor antagonist after traumatic brain injury in rats. [2019]
NNZ-2566 treatment inhibits neuroinflammation and pro-inflammatory cytokine expression induced by experimental penetrating ballistic-like brain injury in rats. [2021]
A 5-HT6R agonist alleviates cognitive dysfunction after traumatic brain injury in rats by increasing BDNF expression. [2022]
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