MitoQ for Fatigue in Multiple Sclerosis
Status: | Recruiting |
---|---|
Conditions: | Other Indications, Neurology, Neurology, Multiple Sclerosis |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 2/21/2019 |
Start Date: | September 15, 2018 |
End Date: | September 15, 2020 |
Contact: | Allison Fryman, MPH |
Email: | fryman@ohsu.edu |
Phone: | 503-220-8262 |
MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial
The purpose of this study is to determine whether MS patients who receive Oral mitoquinone
(MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's
fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if
MitoQ has a significant change in fatigue.
(MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's
fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if
MitoQ has a significant change in fatigue.
MitoQ is a potent antioxidant dietary supplement with potentially significant
immunomodulatory and anti-inflammatory properties. While the cause of MS related fatigue is
uncertain, the investigators believe that mitochondria dysfunction and resultant neuronal
energy depletion may be an important contributor to fatigue in MS.
This clinical trial will evaluate the potential beneficial effects of MitoQ on MS fatigue. It
will also explore the effects of MitoQ on cognitive function, quality of life and mood. If
enrolled in the study, patients will take two capsules of the study drug or placebo at the
same time every day for twelve weeks. There will be 4 study visits where the participant will
undergo medical and nervous system examinations, questionnaires, and blood draws. Because it
is a placebo-controlled trial, participants will have a 33% chance of receiving either
placebo (inactive), 20mg of MitoQ, or 40mg of MitoQ. This will be a blinded randomized study,
meaning neither the participant nor the investigator will know who received the placebo or
study drug.
immunomodulatory and anti-inflammatory properties. While the cause of MS related fatigue is
uncertain, the investigators believe that mitochondria dysfunction and resultant neuronal
energy depletion may be an important contributor to fatigue in MS.
This clinical trial will evaluate the potential beneficial effects of MitoQ on MS fatigue. It
will also explore the effects of MitoQ on cognitive function, quality of life and mood. If
enrolled in the study, patients will take two capsules of the study drug or placebo at the
same time every day for twelve weeks. There will be 4 study visits where the participant will
undergo medical and nervous system examinations, questionnaires, and blood draws. Because it
is a placebo-controlled trial, participants will have a 33% chance of receiving either
placebo (inactive), 20mg of MitoQ, or 40mg of MitoQ. This will be a blinded randomized study,
meaning neither the participant nor the investigator will know who received the placebo or
study drug.
Inclusion Criteria:
- MS (any clinical subtype) as diagnosed by the 2010 McDonald criteria40;
- Expanded Disability Status Scale (EDSS) score of 2 to 8,
- Complaint of fatigue that has been persistent for at least two months;
- Modified Fatigue Impact Scale (MFIS) score of 38 or greater
Exclusion Criteria:
- Treatment with systemic glucocorticoids in the prior six weeks;
- Beck Depression Inventory (BDI) >31 (severe depression);
- Significant MS exacerbation in prior 30 days;
- Previous use of MitoQ or CoQ-10 within 30 days of screening appointment;
- Use of non-research-pharmacy-administered MitoQ or CoQ-10 during the duration of the
study;
- Other significant health problem (e.g. active coronary heart disease, liver disease,
pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing
adverse events),
- Pregnancy or intending to become pregnant or breastfeeding;
- Unable to complete the self-report forms;
- Unable to give informed consent;
- Prisoners will be excluded.
- Any condition which would make the patient, in the opinion of the investigator,
unsuitable for the study.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Vijayshree Yadav, MBBS, MCR
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
Click here to add this to my saved trials