Aerobic Exercise with Omaveloxolone in Friedreich's Ataxia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will recruit 30 participants with Friedreich's ataxia, randomizing 20 to receive omaveloxolone in addition to aerobic exercise and 10 to aerobic exercise alone. Participants will undergo baseline tests including CPET, mFARS, gait speed, TUG, fatigue scales, and 6-minute walk, followed by 3 months of at-home aerobic training, with follow-up assessments at 3 and 6 months. The trial aims to assess whether combining omaveloxolone with aerobic training improves objective measures of aerobic capacity and reduces fatigue, while exploring the potential of VO2max as a future primary endpoint for FRDA trials. This design acknowledges prior MOXIe findings on omaveloxolone and seeks more sensitive outcome measures beyond mFARS. Safety and tolerability of the combination will be monitored throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Scott Barbuto, MD PhD
• Email: sb3779@cumc.columbia.edu
• Phone: 12123054818

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Characterizing heart issues in Friedreich's Ataxia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.