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MitoQ for Fatigue in Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis, Fatigue

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mitoquinone
Mitoquinone
Placebo
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring mitoquinone, Fatigue, Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

20mg oral MitoQ

40mg oral MitoQ

Arm Description

20 subjects will receive placebo.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2017
Last Updated
March 31, 2023
Sponsor
Oregon Health and Science University
Collaborators
MitoQ Limited, National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT03166800
Brief Title
MitoQ for Fatigue in Multiple Sclerosis
Acronym
MS
Official Title
MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of adequate funding
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
MitoQ Limited, National Multiple Sclerosis Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Fatigue
Keywords
mitoquinone, Fatigue, Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 subjects will receive placebo.
Arm Title
20mg oral MitoQ
Arm Type
Active Comparator
Arm Description
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.
Arm Title
40mg oral MitoQ
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mitoquinone
Other Intervention Name(s)
mitoquinol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mitoquinone
Other Intervention Name(s)
mitoquinol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.
Primary Outcome Measure Information:
Title
Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation
Description
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.
Time Frame
Baseline to 12 weeks post drug initiation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijayshree Yadav, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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MitoQ for Fatigue in Multiple Sclerosis

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