Trial Outcomes & Findings for Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients (NCT NCT04291066)
NCT ID: NCT04291066
Last Updated: 2026-05-01
Results Overview
Somatic, cognitive, and emotional post-concussion symptoms as measured by, RPQ scores within 24 hours of admission (Day 0), post injury (Day 7), and post injury (Day 30). The scale goes based on a 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, 4 = a severe problem. The RPQ scores can range between 0 and 64 where higher scores indicate more severe symptoms.
COMPLETED
PHASE2
92 participants
0 to 30 days post traumatic brain injury event
2026-05-01
Participant Flow
Participant milestones
| Measure |
Treatment
oral N-acetyl cysteine and oral multivitamin tablets
N-Acetyl cysteine: Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
|
Non-Treatment
Routine Care - Control
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
34
|
31
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
Baseline characteristics by cohort
| Measure |
Non-Treatment
n=31 Participants
Routine Care - Control
|
Total
n=65 Participants
Total of all reporting groups
|
Treatment
n=34 Participants
oral N-acetyl cysteine and oral multivitamin tablets
N-Acetyl cysteine: Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=34 Participants
|
76 years
n=69 Participants
|
77 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=34 Participants
|
34 Participants
n=69 Participants
|
20 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=34 Participants
|
31 Participants
n=69 Participants
|
14 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=34 Participants
|
64 Participants
n=69 Participants
|
34 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=34 Participants
|
65 participants
n=69 Participants
|
34 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 0 to 30 days post traumatic brain injury eventSomatic, cognitive, and emotional post-concussion symptoms as measured by, RPQ scores within 24 hours of admission (Day 0), post injury (Day 7), and post injury (Day 30). The scale goes based on a 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, 4 = a severe problem. The RPQ scores can range between 0 and 64 where higher scores indicate more severe symptoms.
Outcome measures
| Measure |
Treatment
n=34 Participants
oral N-acetyl cysteine and oral multivitamin tablets
N-Acetyl cysteine: Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
|
Non-Treatment
n=31 Participants
Routine Care
|
|---|---|---|
|
Determine Improvement in Somatic, Cognitive, and Emotional Post-concussion Symptoms as Measured by the Rivermeade Post-concussion Questionnaire (RPQ) in Treatment Group vs Non-treatment Group.
Day 0
|
6 score on a scale
Interval 0.0 to 20.0
|
11 score on a scale
Interval 4.0 to 20.0
|
|
Determine Improvement in Somatic, Cognitive, and Emotional Post-concussion Symptoms as Measured by the Rivermeade Post-concussion Questionnaire (RPQ) in Treatment Group vs Non-treatment Group.
Day 7
|
2 score on a scale
Interval 0.0 to 8.0
|
10 score on a scale
Interval 3.0 to 18.0
|
|
Determine Improvement in Somatic, Cognitive, and Emotional Post-concussion Symptoms as Measured by the Rivermeade Post-concussion Questionnaire (RPQ) in Treatment Group vs Non-treatment Group.
Day 30
|
0 score on a scale
Interval 0.0 to 4.0
|
4 score on a scale
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: Day 0 Score on arrival through subject discharge post traumatic brain injury event at approximately 30 daysThe Glasgow Coma Scale (GCS) is a clinical tool used to assess a person's level of consciousness after a brain injury. The scale covers three primary domains with associated sub scores to generate a total GCS score ranging from 3 - 15. A total score of 3 -8 notes severe dysfunction, 9 - 12 moderate dysfunction, and 13 - 15 mild dysfunction. Sub scores are evaluated as follows: Eye Opening (Score range 1 -4): 1 - None, 2 - To pressure, 3 - To sound, 4 - Spontaneous. Verbal Response (Score range 1-5): 1 - None, 2 - Sounds, 3 - Words, 4 - Confused, 5 - Orientated. Motor Response (Score range 1-6): 1 - None, 2 - Extension, 3 - Abnormal flexion, 4 - Normal flexion, 5 - Localizing, 6 - Obey commands.
Outcome measures
| Measure |
Treatment
n=34 Participants
oral N-acetyl cysteine and oral multivitamin tablets
N-Acetyl cysteine: Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
|
Non-Treatment
n=31 Participants
Routine Care
|
|---|---|---|
|
Glasgow Coma Scale (GCS) at Arrival and Discharge
GCS Score - Arrival
|
15 score on a scale
Standard Deviation 0.2
|
14.9 score on a scale
Standard Deviation 0.3
|
|
Glasgow Coma Scale (GCS) at Arrival and Discharge
GCS Score - Discharge
|
15 score on a scale
Standard Deviation 0.2
|
15 score on a scale
Standard Deviation 0.2
|
Adverse Events
Treatment
Non-Treatment
Serious adverse events
| Measure |
Treatment
n=46 participants at risk
oral N-acetyl cysteine and oral multivitamin tablets
N-Acetyl cysteine: Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
|
Non-Treatment
n=46 participants at risk
Routine Care
|
|---|---|---|
|
Nervous system disorders
Death
|
4.3%
2/46 • Number of events 2 • 5 months
|
10.9%
5/46 • Number of events 5 • 5 months
|
|
Cardiac disorders
Death
|
0.00%
0/46 • 5 months
|
2.2%
1/46 • Number of events 1 • 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.00%
0/46 • 5 months
|
2.2%
1/46 • Number of events 1 • 5 months
|
Other adverse events
Adverse event data not reported
Additional Information
James K. Dzandu, PhD/Trauma Research Manager
HonorHealth
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place