MitoQ for Multiple Sclerosis

(MitoQ Trial)

Overseen By Allison Fryman

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: VA Office of Research and Development

Must not be taking: Glucocorticoids, MitoQ, CoQ10

Disqualifiers: Severe depression, Coronary disease, Diabetes, others

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether MitoQ, a potential new treatment, can reduce fatigue in people with Multiple Sclerosis (MS). Participants will receive either a placebo or one of two doses of MitoQ. The goal is to determine if MitoQ significantly reduces fatigue after 12 weeks. Suitable candidates have MS and have experienced fatigue for at least two months. As a Phase 1, Phase 2 trial, this research aims to understand how MitoQ works in people and to measure its effectiveness in reducing fatigue in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used MitoQ or CoQ10 in the 30 days before the screening. Also, you should not have been treated with systemic glucocorticoids in the six weeks before the trial.

Is there any evidence suggesting that MitoQ is likely to be safe for humans?

Research has shown that MitoQ, a treatment being tested for fatigue in multiple sclerosis (MS), has been safe in earlier studies. One study found that MitoQ improved blood vessel function without causing serious side effects, indicating it is well-tolerated.

Other research highlights that MitoQ acts as an antioxidant, helping to protect cells from damage. This protective quality may contribute to its safety. Additionally, tests of MitoQ in various doses have reported no major negative effects.

Since this trial is in its early stages, it focuses on how well participants can tolerate the treatment. While MitoQ is not yet approved for MS, current evidence suggests it is safe for human use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for MS?

Unlike the standard treatments for multiple sclerosis, which often focus on modulating the immune system or managing symptoms, MitoQ offers a unique approach by targeting mitochondrial dysfunction. MitoQ is a powerful antioxidant that specifically targets mitochondria, potentially reducing oxidative stress, which is believed to play a role in the progression of multiple sclerosis. Researchers are excited about MitoQ because it represents a novel mechanism of action that could complement existing therapies by directly protecting nerve cells from damage. This could potentially lead to better outcomes for patients with multiple sclerosis, offering new hope where current treatments may fall short.

What evidence suggests that MitoQ might be an effective treatment for multiple sclerosis fatigue?

Research has shown that MitoQ, a special antioxidant targeting the energy centers in cells, might help reduce tiredness in people with multiple sclerosis (MS). In studies, MitoQ led to a small improvement in tiredness and mood compared to a placebo. It also slowed the progression of the disease in lab models, suggesting a protective effect. These findings support the idea that MitoQ could help manage MS symptoms like fatigue. Participants in this trial will receive either a placebo or one of two dosages of MitoQ to further evaluate its effectiveness. ^{1 4 5 6 7}

Who Is on the Research Team?

Vijayshree Yadav, MBBS

Principal Investigator

VA Portland Health Care System, Portland, OR

Are You a Good Fit for This Trial?

This trial is for MS patients with persistent fatigue and an MFIS score of 38 or higher. They must have been diagnosed by the McDonald criteria, have an EDSS score between 2 to 8, and not be severely depressed. People can't join if they've used steroids recently, are pregnant/breastfeeding, have certain health issues like heart or liver disease, or were on MitoQ/CoQ10 in the last month.

Inclusion Criteria

I have been feeling tired for at least two months.

I have been diagnosed with multiple sclerosis according to the 2017 criteria.

My disability score is between 2 and 8.

Exclusion Criteria

I haven't taken MitoQ or CoQ10 in the last 30 days.

You have a score higher than 31 on the Beck Depression Inventory or higher than 10 on the BDI-FS, indicating severe depression.

I do not have any major health issues that could worsen by participating in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or MitoQ (20mg or 40mg) daily for 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MitoQ

Trial Overview The study tests if MitoQ reduces fatigue in MS patients compared to a placebo. Participants will either take a daily dose of MitoQ (20mg or 40mg) or a placebo for 12 weeks. Their levels of fatigue at the start and after treatment will show if there's any improvement.

How Is the Trial Designed?

Group I: 20mg of MitoQ Active Control 1 Intervention

20mg of oral mitoquinol

Group II: 40mg of MitoQ Active Control 1 Intervention

40mg of Oral Mitoquinol

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04267926?term=mitoQ&draw=2&rank=3

NCT04267926 | MitoQ for Fatigue in Multiple Sclerosis (MS) 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03166800

MitoQ for Fatigue in Multiple Sclerosis (MS) The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667137922000091

Pharmacological significance of MitoQ in ameliorating ... They demonstrated that MitoQ improved fine motor function and learning impairment caused by rmTBI, possibly by reducing astrocytosis, microgliosis, dendritic ...

4. grantome.com grantome.com/grant/NIH/I01-CX001955-01A1

MitoQ for Fatigue in Multiple Sclerosis: A Placebo ... This study showed significant albeit modest improvement in fatigue and mood in CoQ10 treated subjects as compared to placebo. Oral Mitoquinone (MitoQ) is a more ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24055980/

MitoQ, a mitochondria-targeted antioxidant, delays disease ... MitoQ, a mitochondria-targeted antioxidant, delays disease progression and alleviates pathogenesis in an experimental autoimmune encephalomyelitis mouse model ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04267926

NCT04267926 | MitoQ for Fatigue in Multiple Sclerosis (MS) A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

7. mitoq.com mitoq.com/pages/research?srsltid=AfmBOoowEyh6BdfuNl-YrEO5h0T1nqxdlW5D2-cxA-fz7ShWsLyaGuWM

mitoquinol mesylate research studies & clinical trials In this clinical trial it was confirmed that: MitoQ greatly improved the ability of arteries to dilate (by 42%). MitoQ significantly supports the health of ...