Multiple SclerosisPhase 1/2MSNCT03166800
MitoQ for Fatigue in Multiple Sclerosis
A Phase 1/2 study testing Mitoquinone in people with Multiple Sclerosis and Fatigue, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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 study drug initiation will assess if MitoQ has a significant change in fatigue. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue
- What is being tested?
- Mitoquinone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2018to 10 Jan 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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 study drug initiation will assess if MitoQ has a significant change in fatigue.
Read the detailed description
MitoQ is a potent antioxidant 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.
- Conditions
- Multiple Sclerosis, Fatigue
- Being tested
- Mitoquinone, Placebo
- Keywords
- mitoquinone, Fatigue, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoquinoneDrug
Also called mitoquinol
This arm of the intervention the study subject will be administered 40mg of the study drug MitoQ orally in capsule form every morning for 12 weeks.
MitoquinoneDrug
Also called mitoquinol
This arm of the intervention the study subject will be administered 20mg of the study drug MitoQ orally in capsule form every morning for 12 weeks.
PlaceboDrug
This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 20 subjects will receive placebo. Receives: Drug: Placebo |
| 20mg oral MitoQ | Active comparator | MitoQ is a potent antioxidant supplement with potentially significant immunomodulatory and anti-inflammatory properties. 20mg of MitoQ will be administered to 20 subjects in this trial. Receives: Drug: Mitoquinone |
| 40mg oral MitoQ | Active comparator | MitoQ is a potent antioxidant supplement with potentially significant immunomodulatory and anti-inflammatory properties. 40mg of MitoQ will be administered to 20 subjects in this trial. Receives: Drug: Mitoquinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation
This primary outcome measure will be the difference from baseline in fatigue scores as measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation.
Measured: Baseline to 12 weeks post drug initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start15 Sep 2018
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Why it stopped: Lack of adequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- MitoQ Limited, National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Vijayshree Yadav, Oregon Health and Science University
- Investigators
- Vijayshree Yadav, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166800
- Sponsor's protocol ID
- STUDY00015779
- Acronym
- MS
- Status last verified
- Mar 2023
- First submitted
- 23 May 2017
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03166800
- Acronym / sponsor ID
- MS / STUDY00015779
- Conditions
- Multiple Sclerosis, Fatigue
- Keywords
- mitoquinone, Fatigue, Multiple Sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of adequate funding
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- MitoQ Limited, National Multiple Sclerosis Society
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 study drug initiation will assess if MitoQ has a significant change in fatigue.
Detailed description
MitoQ is a potent antioxidant 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo20 subjects will receive placebo. |
| 20mg oral MitoQ | Active comparator | Drug: MitoquinoneMitoQ is a potent antioxidant supplement with potentially significant immunomodulatory and anti-inflammatory properties. 20mg of MitoQ will be administered to 20 subjects in this trial. |
| 40mg oral MitoQ | Active comparator | Drug: MitoquinoneMitoQ is a potent antioxidant supplement with potentially significant immunomodulatory and anti-inflammatory properties. 40mg of MitoQ will be administered to 20 subjects in this trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoquinoneAlso: mitoquinolThis arm of the intervention the study subject will be administered 40mg of the study drug MitoQ orally in capsule form every morning for 12 weeks. | Drug | 40mg oral MitoQ |
| MitoquinoneAlso: mitoquinolThis arm of the intervention the study subject will be administered 20mg of the study drug MitoQ orally in capsule form every morning for 12 weeks. | Drug | 20mg oral MitoQ |
| PlaceboThis arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks. | Drug | Placebo |
Primary outcome
Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation
Time frame: Baseline to 12 weeks post drug initiation.
This primary outcome measure will be the difference from baseline in fatigue scores as measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation.
Results and safety
The study was stopped early (reason given: Lack of adequate funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijayshree Yadav, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mitoquinone in people with Multiple Sclerosis and Fatigue, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of adequate funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation (time frame: Baseline to 12 weeks post drug initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.