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| ID | Type | Description | Link |
|---|---|---|---|
| 4337 | Other Grant/Funding Number | CSR&D |
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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.
Recruitment of subjects on hold due to COVID-19 pandemic
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| 20mg of MitoQ | Active Comparator | 20mg of oral mitoquinol |
|
| 40mg of MitoQ | Active Comparator | 40mg of Oral Mitoquinol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 mg MitoQ | Drug | a third of subject will receive 20mg of oral MitoQ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Fatigue Inventory Scale (MFIS) | MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue. | Week 1, Week 7, Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Symbol Digit Modalities Test (SDMT) | SDMT measures cognitive function. Scale 0-110. Higher scores reflect a better outcome. | Week 1, Week 7, Week 13 |
| Expanded Disability Status Scale (EDSS) | EDSS measures neurological function. Scale 0-10 |
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Inclusion Criteria:
Exclusion Criteria:
treatment with systemic glucocorticoids in the prior six weeks
Beck Depression Inventory (BDI) >31 or BDI-FS>10 (severe depression)
significant MS exacerbation in prior 30 days
previous use of MitoQ or Coenzyme Q10 (CoQ10) within thirty days of screening appointment
other significant health problem that might increase risk of patient experiencing Adverse Events (AEs), e.g.:
pregnancy or intending to become pregnant or breastfeeding
unable to complete the self-report forms
unable to give informed consent
prisoners
any condition which would make the patient in the opinion of the investigator unsuitable for the study
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| Name | Affiliation | Role |
|---|---|---|
| Vijayshree Yadav, MBBS | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97207-2964 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Capsule containing Placebo ingredient. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | 20mg of MitoQ | 20mg of oral mitoquinol |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Fatigue Inventory Scale (MFIS) | MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue. | Posted | Mean | Standard Error | units on a scale | Week 1, Week 7, Week 13 |
|
From enrollment to end of follow-up (13 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | ClinicalTrials.gov | Systematic Assessment | Had fall while taking recycling bin outside, the sun shone very bright in eyes and fell on side and injured nose. Did not seek medical attention and healed on own. Has been very light sensitive as a preexisting condition. |
While the original sample size was 60 we were able to enroll only 45 subjects out of which 43 completed all visits. The study was affected due to COVID-19 and OHSU/VA contract delays.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vijayshree Yadav MBBS, MCR | Department of Veterans Affairs MS Center of Excellence-West and Portland, Oregon Health & Science University | 503-494-3813 | yadavv@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2021 | Oct 15, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2019 | Jan 23, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C429014 | mitoquinone |
| C429015 | mitoquinol |
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Double-blind, randomized trial
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The subject and investigator will be blinded.
| Placebo | Drug | Subject will receive Placebo |
|
| 40mg of MitoQ | Drug | a third of subjects will receive 40mg of MitoQ |
|
|
| 12 weeks |
| Beck's Depression Inventory (BDI) | BDI is a self-reported questionnaire measuring depression. Scale 0-21 | 12 weeks |
| 40mg of MitoQ |
40mg of Oral Mitoquinol |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Symbol Digit Modalities Test (SDMT) | SDMT measures cognitive function. Scale 0-110. Higher scores reflect a better outcome. | Posted | Mean | Standard Error | units on a scale | Week 1, Week 7, Week 13 |
|
|
|
| Secondary | Expanded Disability Status Scale (EDSS) | EDSS measures neurological function. Scale 0-10 | Not Posted | 12 weeks | Participants |
| Secondary | Beck's Depression Inventory (BDI) | BDI is a self-reported questionnaire measuring depression. Scale 0-21 | Not Posted | 12 weeks | Participants |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | 20mg of MitoQ | 20mg of oral mitoquinol | 0 | 15 | 0 | 15 | 1 | 15 |
| EG002 | 40mg of MitoQ | 40mg of Oral Mitoquinol | 0 | 14 | 0 | 14 | 1 | 14 |
|
| Cold | General disorders | ClinicalTrials.gov | Systematic Assessment | Cold Like symptoms |
|
| Hot Flashes | Reproductive system and breast disorders | ClinicalTrials.gov | Systematic Assessment | Had hot flashes after study started. Similar episode in the past while on estradiol patch. |
|
| Flu | General disorders | ClinicalTrials.gov | Systematic Assessment | Flu like symptoms |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Week 13 |
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