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NCT07444333
Cardiac Output and Fatigue in Friedreich's Ataxia
NA trial testing Aerobic Exercise in Friedreich's Ataxia in 30 participants. Not yet recruiting.
1 February 2028
Quick facts
| Lead sponsor | Scott Barbuto |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 April 2026 |
| Primary completion | 1 February 2028 |
| Estimated completion | 1 April 2028 |
Drugs / interventions tested
- Aerobic Exercise — full drug profile →
- Omeveloxolone — full drug profile →
Conditions studied
- Friedreich's Ataxia — all drugs for Friedreich's Ataxia →
Sponsor
Scott Barbuto — full company profile →
Who can join
Eligibility, any sex, with Friedreich's Ataxia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
AIM 1: Acceptability and Feasibility of Home Aerobic Exercise. Individuals with other types of ataxia have been able to train at the above levels safely. We hypothesize that there will be no serious adverse events related to aerobic training, and there will be an acceptable number of minor adverse events. We further hypothesize that drop-out from the trial will be less than 25%. AIM 2: Impact of Omaveloxolone on VO2max. Omaveloxolone works by activating and preventing the degradation of Nuclear factor-like 2 (Nrf2), which helps prevent oxidative damage within the mitochondria of individuals with FRDA. Improved mitochondrial function should significantly enhance VO2max by increasing ATP production and improving the rate of oxygen consumption. Thus, we hypothesize that individuals on omaveloxolone will have a significantly larger increase in VO2max after the aerobic training when compared to individuals who are not on omaveloxolone. AIM 3: Impact of Aerobic Training + Omaveloxolone on Fatigue. Omaveloxolone has been shown to cause a transient (12-week) increase in fatigue. Aerobic training, on the other hand, is known to improve fatigue in individuals with other hereditary ataxias. For this aim, the primary outcome measure will be the Fatigue Severity Scale (FSS) with secondary measures of Fatigue Impact Scale (FIS) and 6-minute walk test (6MWT). We hypothesize improved fatigue with the incorporation of aerobic training and that individuals in the omaveloxolone group will have less fatigue than those not on omaveloxolone.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07444333
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Related trials
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Trials testing the same drug.
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Other recruiting trials for Friedreich's Ataxia
Currently open trials in the same condition.
- NCT07095062 — Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome. · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07444333 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Scott Barbuto
- Last refreshed: 2 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07444333.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing