drugset / Trial / NCT07444333
Cardiac Output and Fatigue in Friedreich's Ataxia
Non-randomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2026-07-15
- Primary completion
- 2028-02-01
- Completion
- 2028-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omaveloxolone | Small molecule | — | — |