Trial Outcomes & Findings for A Study of Oxidative Pathways in MS Fatigue (NCT NCT02804594)
NCT ID: NCT02804594
Last Updated: 2025-07-11
Results Overview
Number of adverse events reported since baseline visit that are related to N-acetyl cysteine will be compared to the number of adverse events reported by participants in the placebo group.
COMPLETED
PHASE2
15 participants
4 weeks
2025-07-11
Participant Flow
Our study participants are recruited from the MS Clinic.
Study participants who met the eligibility criteria to enroll in the study are randomized into study medication group or placebo group. Study participants who did not meet the criteria to enter the study treatment period of the study were observed as controls.
Participant milestones
| Measure |
N-acetyl Cysteine
1250 mg of N-acetyl cysteine three times daily
N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily
|
Placebo
placebo three times daily
Placebo: placebo taken three times daily
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Oxidative Pathways in MS Fatigue
Baseline characteristics by cohort
| Measure |
N-acetyl Cysteine
n=10 Participants
1250 mg of N-acetyl cysteine three times daily
N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily
|
Placebo
n=5 Participants
placebo three times daily
Placebo: placebo taken three times daily
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Modified Fatigue Impact Scale (MFIS) score at baseline
|
48.5 Scores on a scale
n=5 Participants
|
50 Scores on a scale
n=7 Participants
|
50 Scores on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Study participants enrolled in the treatment period are included in the analysis.
Number of adverse events reported since baseline visit that are related to N-acetyl cysteine will be compared to the number of adverse events reported by participants in the placebo group.
Outcome measures
| Measure |
N-acetyl Cysteine
n=10 Participants
1250 mg of N-acetyl cysteine three times daily
N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily
|
Placebo
n=5 Participants
placebo three times daily
Placebo: placebo taken three times daily
|
|---|---|---|
|
Number of Adverse Events Reported Since Baseline Visit That Are Related to N-acetyl Cysteine.
|
12 adverse events
|
6 adverse events
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study participants enrolled in the treatment period are included in the analysis.
Change in fatigue score on questionnaires from baseline visit to week-4 is calculated for the Modified Fatigue Impact Scale (MFIS) questionnaire. The MFIS is a self-report measure to rate fatigue in Multiple Sclerosis. The total score, ranging from 0 to 84 is the sum of three subscales (physical, cognitive, and psychosocial functioning). Higher numbers indicate greater fatigue. Modified fatigue Impact scale of more than 38 is one of the inclusion criteria for the study. Study participants who scored higher value on the questionnaire at week-4 are considered to have worsened fatigue from the baseline visit.
Outcome measures
| Measure |
N-acetyl Cysteine
n=10 Participants
1250 mg of N-acetyl cysteine three times daily
N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily
|
Placebo
n=5 Participants
placebo three times daily
Placebo: placebo taken three times daily
|
|---|---|---|
|
Change in Fatigue Score on Questionnaires From Baseline
|
-11.4 scores on a scale
Standard Deviation 14.9
|
-18 scores on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study participants enrolled in the treatment period are included in the analysis.
Baseline to week 4 change in blood GSH/GSSG ratio (wherein GSH is glutathione in reduced state and GSSG is glutathione in oxidized state) and grey matter GSH concentration on 7T MR spectroscopy (MRS) between groups. We hypothesize that fatigue is associated with the GSH/GSSG ratio.
Outcome measures
| Measure |
N-acetyl Cysteine
n=10 Participants
1250 mg of N-acetyl cysteine three times daily
N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily
|
Placebo
n=5 Participants
placebo three times daily
Placebo: placebo taken three times daily
|
|---|---|---|
|
Change in Level of Blood Markers From Baseline
|
-0.1 mean absolute change in GSH/GSSG ratio
Standard Deviation 0.6
|
-0.6 mean absolute change in GSH/GSSG ratio
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksConventional T2/ T1-weighted images will be obtained at baseline for all subjects enrolled in the treatment phase of the study. We will perform brain MRI on 7T machine, and the sequences will be collected at baseline, and week-4 visit.
Outcome measures
Outcome data not reported
Adverse Events
N-acetyl Cysteine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-acetyl Cysteine
n=10 participants at risk
1250 mg of N-acetyl cysteine three times daily
N-acetyl cysteine: 1250 mg of N- acetyl cysteine taken three times daily
|
Placebo
n=5 participants at risk
placebo three times daily
Placebo: placebo taken three times daily
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/10 • Adverse events are collected over 4 weeks
|
20.0%
1/5 • Number of events 1 • Adverse events are collected over 4 weeks
|
|
Infections and infestations
Salivary gland infection
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory-Other, Common cold
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
General disorders
Fatigue
|
0.00%
0/10 • Adverse events are collected over 4 weeks
|
20.0%
1/5 • Number of events 1 • Adverse events are collected over 4 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Adverse events are collected over 4 weeks
|
20.0%
1/5 • Number of events 1 • Adverse events are collected over 4 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Adverse events are collected over 4 weeks
|
20.0%
1/5 • Number of events 1 • Adverse events are collected over 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Adverse events are collected over 4 weeks
|
20.0%
1/5 • Number of events 1 • Adverse events are collected over 4 weeks
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
20.0%
1/5 • Number of events 1 • Adverse events are collected over 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Injury, poisoning and procedural complications
Injury-Other, injury to back
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
|
Injury, poisoning and procedural complications
Injury-Other, Injury to face secondary to a fall
|
10.0%
1/10 • Number of events 1 • Adverse events are collected over 4 weeks
|
0.00%
0/5 • Adverse events are collected over 4 weeks
|
Additional Information
Emmanuelle Waubant, MD
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place