Improving sleep and fatigue in traumatic brain injury patients with NE3107
Open Label Phase IIa Study Evaluating the Safety and Efficacy of NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury
This study is testing if a new medication called NE3107 can help people with traumatic brain injury sleep better and feel less tired.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Neurological Associates of West Los Angeles Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT05970575 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of NE3107, an insulin-sensitizing agent, on sleep quality and fatigue levels in individuals diagnosed with traumatic brain injury (TBI). The study aims to measure cognitive changes through verbal and visual tests, as well as assess biomarkers related to TBI and inflammatory responses. By focusing on neuroinflammation's role in TBI, the trial seeks to understand how reducing inflammation may improve sleep disturbances and fatigue in affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who have been diagnosed with traumatic brain injury and experience significant fatigue and sleep disturbances.
Not a fit: Patients with other chronic neurological conditions or severe psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality and reduced fatigue for patients suffering from traumatic brain injury.
How similar studies have performed: While there is growing interest in the role of neuroinflammation in TBI, this specific approach using NE3107 is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Santa Monica, California
- The Regenesis Project — Santa Monica, California, United States (Recruiting)
Study contacts
- Study coordinator: Kennedy Mahdavi
- Email: kmahdavi@theneuroassociates.com
- Phone: 3108295968
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.