Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02255435) involved people with Friedreich's ataxia, a rare condition affecting movement and coordination. The trial was run in two parts. Part 1 enrolled 69 participants across seven dose groups of a medicine called omaveloxolone (ranging from 2.5 mg up to 300 mg) plus a placebo group of 17 people, to explore different doses over 12 weeks. Part 2 enrolled 103 participants — 52 on placebo and 51 on a 150 mg dose of omaveloxolone — over 48 weeks. Part 1 looked mainly at how hard participants could work on a stationary exercise bike, while Part 2 focused on changes in a neurological function score called the mFARS, where a lower score means better function (the scale runs from 0 to 99). The reported data shows the following numbers. In Part 1, the change in exercise capacity (measured in watts per kilogram of body weight) after 12 weeks ranged from a small increase of 0.14 W/kg in the lowest dose group down to a small decrease of −0.09 W/kg in the 20 mg group; the placebo group showed a change of 0.04 W/kg. In Part 2, after 48 weeks the mFARS score in the placebo group increased by an average of 0.85 points (meaning slightly worse function on average), while the omaveloxolone 150 mg group showed an average change of −1.55 points (meaning a small improvement in score on average). For the secondary measure in Part 1 — the mFARS score at 12 weeks — all groups including placebo showed small reductions in score, ranging from −0.88 to −3.75 across the omaveloxolone doses, compared with −1.43 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40614535) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Friedreich Ataxia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Friedreich's ataxia, confirmed through genetic testing
- Your disease severity falls within a specific range as measured by a scoring system called the modified FARS (confirm with trial site for your exact score)
- You are between 16 and 40 years old (male or female)
- You have not changed your exercise routine in the 30 days before the study starts, and you are willing to keep the same routine for the full 16 weeks of the study
- You are physically able to complete a maximum effort exercise test
- You are able to swallow capsules
Who may not be able to join:
- You have poorly controlled diabetes (based on a blood sugar marker called HbA1c being above a certain level)
- You have an abnormal result on a specific heart stress marker in your blood (confirm with trial site)
- You have a significant heart condition affecting the left side of your heart or another serious heart disease
- You have a known active infection such as HIV, hepatitis B or C, or an active fungal or bacterial infection
- You have a known or suspected problem with drug or alcohol misuse
- You have significantly abnormal blood test results, including certain liver enzyme levels that are notably elevated
- You have any serious existing medical condition or abnormal test result that the study doctor believes would put you at risk by joining
- You have taken certain specific medications within 7 days before the study starts, or plan to take them during the study — these include some diabetes drugs, some sedatives, some antibiotics, some seizure medications, and grapefruit juice, among others (confirm the full list with the trial site)
- You have taken part in another interventional clinical trial within the last 30 days
- You have a cognitive impairment that may make it difficult to follow the study procedures
- You have previously taken part in a trial involving a drug called omaveloxolone (also known as RTA 408)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1; Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.