NCT04267926: MitoQ

MitoQ for Fatigue in Multiple Sclerosis (MS)

Active, enrolled Phase 1, PHASE2 Results posted Last updated 17 March 2026

What this trial tests

Phase 1, PHASE2 trial testing 20 mg MitoQ in Multiple Sclerosis in 45 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 April 2020

Primary endpoint
15 October 2024

31 March 2026

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	45
Start date	1 April 2020
Primary completion	15 October 2024
Estimated completion	31 March 2026
Sites	1 location across United States

Drugs / interventions tested

• 20 mg MitoQ — full drug profile →
• Placebo
• 40mg of MitoQ — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Fatigue — all drugs for Fatigue →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 70, any sex, with Multiple Sclerosis or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Modified Fatigue Inventory Scale (MFIS) Primary · Week 1, Week 7, Week 13

MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue.

Week 1

Group	Value	95% CI
Placebo	46.5	± 2.8
20mg of MitoQ	55.2	± 2.8
40mg of MitoQ	54.3	± 2.9

Week 7

Group	Value	95% CI
Placebo	45.1	± 3.1
20mg of MitoQ	50.5	± 2.9
40mg of MitoQ	49	± 3.1

Week 13

Group	Value	95% CI
Placebo	39.7	± 2.8
20mg of MitoQ	48.7	± 2.8
40mg of MitoQ	47.8	± 3

Symbol Digit Modalities Test (SDMT) Secondary · Week 1, Week 7, Week 13

SDMT measures cognitive function. Scale 0-110. Higher scores reflect a better outcome.

Week 1

Group	Value	95% CI
Placebo	31.3	± 8.4
20mg of MitoQ	25.9	± 8.1
40mg of MitoQ	33.3	± 8.4

Week 7

Group	Value	95% CI
Placebo	33.2	± 8.0
20mg of MitoQ	28.8	± 8.0
40mg of MitoQ	36.1	± 8.2

Week 13

Group	Value	95% CI
Placebo	32.6	± 8.4
20mg of MitoQ	30.4	± 8.1
40mg of MitoQ	35.6	± 8.2

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment to end of follow-up (13 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/16 (0%)

Deaths: 0/16

20mg of MitoQ

Serious: 0/15 (0%)

Deaths: 0/15

40mg of MitoQ

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (4 terms — click to expand)

Reaction	System	Placebo	20mg of MitoQ	40mg of MitoQ
Fall	Injury, poisoning and procedural complications	—	—	—
Cold	General disorders	—	—	—
Hot Flashes	Reproductive system and breast disorders	—	—	—
Flu	General disorders	—	—	—

Data from ClinicalTrials.gov NCT04267926 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial dysfunction: mechanisms and advances in therapy.
   Zong Y, Li H, Liao P, Chen L, et al · · 2024 · cited 614× · PMID 38744846 · DOI 10.1038/s41392-024-01839-8
2. Mitophagy and the Brain.
   Swerdlow NS, Wilkins HM. · · 2020 · cited 51× · PMID 33352896 · DOI 10.3390/ijms21249661
3. Therapeutic Strategies Targeting Mitochondrial Calcium Signaling: A New Hope for Neurological Diseases?
   Rodríguez LR, Lapeña-Luzón T, Benetó N, Beltran-Beltran V, et al · · 2022 · cited 29× · PMID 35052668 · DOI 10.3390/antiox11010165
4. Multifaceted functions of Drp1 in hypoxia/ischemia-induced mitochondrial quality imbalance: from regulatory mechanism to targeted therapeutic strategy.
   Hao S, Huang H, Ma RY, Zeng X, et al · · 2023 · cited 28× · PMID 37833768 · DOI 10.1186/s40779-023-00482-8
5. Is Mitochondrial Oxidative Stress a Viable Therapeutic Target in Preeclampsia?
   Vaka R, Deer E, LaMarca B. · · 2022 · cited 16× · PMID 35204094 · DOI 10.3390/antiox11020210
6. A Narrative Review on Axonal Neuroprotection in Multiple Sclerosis.
   Collongues N, Becker G, Jolivel V, Ayme-Dietrich E, et al · · 2022 · cited 14× · PMID 35610531 · DOI 10.1007/s40120-022-00363-7
7. Effect of Cellular Senescence in Disease Progression and Transplantation: Immune Cells and Solid Organs.
   Kirchner VA, Badshah JS, Hong SK, Martinez O, et al · · 2024 · cited 8× · PMID 37953486 · DOI 10.1097/tp.0000000000004838
8. Molecular and Physiological Determinants of Amyotrophic Lateral Sclerosis: What the DJ-1 Protein Teaches Us.
   Sandrelli F, Bisaglia M. · · 2023 · cited 5× · PMID 37108835 · DOI 10.3390/ijms24087674