Trial Outcomes & Findings for MitoQ for Fatigue in Multiple Sclerosis (MS) (NCT NCT04267926)
NCT ID: NCT04267926
Last Updated: 2025-11-13
Results Overview
MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Week 1, Week 7, Week 13
Results posted on
2025-11-13
Participant Flow
Patients seen at the Multiple Sclerosis at Portland VA Medical Center (PORVAMC)and Oregon Health \& Science University (OHSU) were main sources of recruitment. PORVAMC and OHSU MS clinics neurologists' referrals, chart reviews of MS patients at PORVAMC and OHSU Electronic medical records using the Mychart tool were used for help with recruitment. We additionally reached to a wide network of interested referring physicians from Portland and its surrounding areas.
Out of 46 screened subjects, 45 were randomized. One subject was NOT randomized due to abnormal screening labs. Two subjects were excluded after randomization (one subject had abnormal screening labs, second subject received IV Iron infusion for anemia). Thus, data from 43 subjects is available for the statistical analysis.
Participant milestones
| Measure |
Placebo
Capsule containing Placebo ingredient.
|
20 mg of MitoQ
This group received one pill of the placebo and the second pill containing 20 mg of oral Mitoquinol (active drug) by mouth. Study drug was given empty stomach as described in the protocol.
|
40mg of MitoQ
This group received two pills, each containing 20 mg of oral Mitoquinol (active drug) thus total dose of 40 mg Mitoquinol, by mouth. Study drug was given empty stomach as described in the protocol.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Capsule containing Placebo ingredient.
|
20 mg of MitoQ
This group received one pill of the placebo and the second pill containing 20 mg of oral Mitoquinol (active drug) by mouth. Study drug was given empty stomach as described in the protocol.
|
40mg of MitoQ
This group received two pills, each containing 20 mg of oral Mitoquinol (active drug) thus total dose of 40 mg Mitoquinol, by mouth. Study drug was given empty stomach as described in the protocol.
|
|---|---|---|---|
|
Overall Study
abnormal labs. No longer eligible
|
0
|
0
|
1
|
|
Overall Study
Iron infusion for fatigue. No longer eligible for study.
|
1
|
0
|
0
|
Baseline Characteristics
MitoQ for Fatigue in Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Placebo
|
20mg of MitoQ
n=15 Participants
20mg of oral mitoquinol
|
40mg of MitoQ
n=14 Participants
40mg of Oral Mitoquinol
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.8 Years
STANDARD_DEVIATION 8.46 • n=10 Participants
|
55.7 Years
STANDARD_DEVIATION 9.32 • n=10 Participants
|
52.6 Years
STANDARD_DEVIATION 12.06 • n=20 Participants
|
54.42 Years
STANDARD_DEVIATION 9.83 • n=45 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=10 Participants
|
12 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
34 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
11 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=10 Participants
|
15 Participants
n=10 Participants
|
13 Participants
n=20 Participants
|
44 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 7, Week 13MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
20mg of MitoQ
n=15 Participants
20mg of oral mitoquinol
|
40mg of MitoQ
n=14 Participants
40mg of Oral Mitoquinol
|
|---|---|---|---|
|
Modified Fatigue Inventory Scale (MFIS)
Week 1
|
46.5 units on a scale
Standard Error 2.8
|
55.2 units on a scale
Standard Error 2.8
|
54.3 units on a scale
Standard Error 2.9
|
|
Modified Fatigue Inventory Scale (MFIS)
Week 7
|
45.1 units on a scale
Standard Error 3.1
|
50.5 units on a scale
Standard Error 2.9
|
49 units on a scale
Standard Error 3.1
|
|
Modified Fatigue Inventory Scale (MFIS)
Week 13
|
39.7 units on a scale
Standard Error 2.8
|
48.7 units on a scale
Standard Error 2.8
|
47.8 units on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: Week 1, Week 7, Week 13SDMT measures cognitive function. Scale 0-110. Higher scores reflect a better outcome.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
20mg of MitoQ
n=15 Participants
20mg of oral mitoquinol
|
40mg of MitoQ
n=14 Participants
40mg of Oral Mitoquinol
|
|---|---|---|---|
|
Symbol Digit Modalities Test (SDMT)
Week 1
|
31.3 units on a scale
Standard Error 8.4
|
25.9 units on a scale
Standard Error 8.1
|
33.3 units on a scale
Standard Error 8.4
|
|
Symbol Digit Modalities Test (SDMT)
Week 7
|
33.2 units on a scale
Standard Error 8.0
|
28.8 units on a scale
Standard Error 8.0
|
36.1 units on a scale
Standard Error 8.2
|
|
Symbol Digit Modalities Test (SDMT)
Week 13
|
32.6 units on a scale
Standard Error 8.4
|
30.4 units on a scale
Standard Error 8.1
|
35.6 units on a scale
Standard Error 8.2
|
SECONDARY outcome
Timeframe: 12 weeksEDSS measures neurological function. Scale 0-10
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksBDI is a self-reported questionnaire measuring depression. Scale 0-21
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
20mg of MitoQ
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
40mg of MitoQ
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Placebo
|
20mg of MitoQ
n=15 participants at risk
20mg of oral mitoquinol
|
40mg of MitoQ
n=14 participants at risk
40mg of Oral Mitoquinol
|
|---|---|---|---|
|
General disorders
Flu
|
0.00%
0/16 • From enrollment to end of follow-up (13 weeks)
|
0.00%
0/15 • From enrollment to end of follow-up (13 weeks)
|
7.1%
1/14 • From enrollment to end of follow-up (13 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • From enrollment to end of follow-up (13 weeks)
|
0.00%
0/15 • From enrollment to end of follow-up (13 weeks)
|
0.00%
0/14 • From enrollment to end of follow-up (13 weeks)
|
|
General disorders
Cold
|
6.2%
1/16 • From enrollment to end of follow-up (13 weeks)
|
0.00%
0/15 • From enrollment to end of follow-up (13 weeks)
|
0.00%
0/14 • From enrollment to end of follow-up (13 weeks)
|
|
Reproductive system and breast disorders
Hot Flashes
|
0.00%
0/16 • From enrollment to end of follow-up (13 weeks)
|
6.7%
1/15 • From enrollment to end of follow-up (13 weeks)
|
0.00%
0/14 • From enrollment to end of follow-up (13 weeks)
|
Additional Information
Vijayshree Yadav MBBS, MCR
Department of Veterans Affairs MS Center of Excellence-West and Portland, Oregon Health & Science University
Phone: 503-494-3813
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place