NCT03166800

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 multiple-sclerosis

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

May 23, 2017

Last Update Submit

March 31, 2023

Conditions

Multiple SclerosisFatigue

Keywords

mitoquinoneFatigueMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 12 weeks post drug initiation.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

20 subjects will receive placebo.

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.

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.

Drug: Mitoquinone

Interventions

MitoquinoneDRUG

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.

Also known as: mitoquinol
40mg oral MitoQ
PlaceboDRUG

This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple SclerosisFatigue

Interventions

mitoquinonemitoquinol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vijayshree Yadav, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MCR, FANA

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 25, 2017

Study Start

September 15, 2018

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

April 5, 2023

Record last verified: 2023-03

Locations

US(1)