Recruiting

Omaveloxolone with Aerobic Training

Sponsor:

Scott Barbuto

Code:

NCT07444333

Conditions

Friedreich's Ataxia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Aerobic Exercise

Study Details

Brief summary:

This is a clinical trial examining to impact of aerobic training plus omaveloxolone in FRDA. Thirty individuals with FRDA will be recruited; 20 individuals will be on omaveloxolone treatment whereas the other ten individuals will not. Individuals will undergo baseline assessment including cardiopulmonary exercise testing (CPET), mFARS, gait speed, Timed Up and Go (TUG), Fatigue Severity Scale (FSS), Fatigue Impact Scale (FIS), and 6-minute Walk Test (6MWT). Individuals will then perform 3-months of home aerobic training. Repeat assessments will be conducted at 3- and 6-months.

Conditions

Friedreich's Ataxia

Study ID

NCT07444333

Start date

Jul 15, 2026

Status verified date

Sep, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Genetically confirmed FRDA
2. Ability to safely ride a stationary bicycle (mFARS sitting posture sub-score <2)

Exclusion Criteria:

1. Beck depression score >19, a score that precludes ability to exercise.
2. Montreal Cognitive Assessment (MoCA) score <23/30
3. Disorders that interfere with ability to perform endurance exercise (e.g., stroke, respiratory problems, traumatic brain injury, or neuromuscular disease).
4. Regular participation in vigorous endurance exercise (defined as >2 days/week for at least the past 4 months at max HR>65%).
5. Evidence of serious arrhythmias or ischemic heart disease.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home Aerobic Training on Omaveloxolone

Participants who are currently taking Skyclarys (omaveloxolone) will be given a recumbent exercise bike (Marcy ME-709 Adjustable Recumbent Exercise Bike, Pomona, CA) for home use. They will be instructed to exercise five times a week. The regimen will include 5-minute warm up, 30 minutes of exercise at target heart rate, and 5 minutes of cool down.

active comparator: Home Aerobic Training off Omaveloxolone

Participants who are not taking Skyclarys (omaveloxolone) will be given a recumbent exercise bike (Marcy ME-709 Adjustable Recumbent Exercise Bike, Pomona, CA) for home use. They will be instructed to exercise five times a week. The regimen will include 5-minute warm up, 30 minutes of exercise at target heart rate, and 5 minutes of cool down.

Interventions

Aerobic Exercise

Both groups will receive aerobic training. The difference will be whether individuals are on or off omaveloxolone.

Primary outcome measure

  • Adverse events (Primary outcome for Aim 1) [ Time Frame: 0, 3, 6 months ]
  • Maximal Oxygen Consumption (primary outcome measure for Aim 2) [ Time Frame: 0, 3-, 6-months ]
  • Fatigue Severity scale (primary outcome measure for Aim 3) [ Time Frame: 0, 3-, and 6-months ]

Central Contacts and Locations

Central contacts

Scott Barbuto, MD PhD

12123054818sb3779@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Scott M Barbuto, MD PhD

212-305-3535sb3779@cumc.columbia.edu

Principal Investigator:

Scott M Barbuto, MD PhD

More Information

Sponsor

Scott Barbuto

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Friedreich's ataxia
  • Aerobic exercise
  • Omaveloxolone
  • Fatigue
  • Cardiac Output

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Scott Barbuto on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.