What is omaveloxolone studying for Friedreich's Ataxia?

Omaveloxolone is being studied to understand its long-term safety in people with Friedreich's Ataxia. Researchers want to learn about serious side effects, including heart and liver-related issues, when the drug is prescribed in real-world settings. The study is sponsored by Biogen and involves collecting health information over several years.

Who may be eligible for this Friedreich's Ataxia clinical trial?

People 16 years or older diagnosed with Friedreich's Ataxia confirmed by genetic testing may be eligible. Participants must be either starting omaveloxolone treatment or have started it less than 12 months ago, currently receiving treatment, and have their doctor involved in the study. Please review eligibility criteria for more details.

Is there any cost to participate in this Friedreich's Ataxia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Age: 16Years +

All Genders

ID06623890

Long-Term Safety Study of Omaveloxolone BIIB141 in People With Friedreichs Ataxia Prescribed by Their Doctors

Led by Biogen · Updated on 2026-04-28

300

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term safety of a drug called BIIB141, also known as omaveloxolone or SKYCLARYS4, in people with Friedreichs Ataxia FA. This observational study collects health information from participants without changing their medical care. It involves participants from the Friedreichs Ataxia Global Clinical Consortium FA GCC UNIFIED Natural History Study UNIFAI to better understand how FA affects patients and to monitor safety events related to the drug. Participants are divided into two groups those who will start omaveloxolone treatment as prescribed by their doctors during the study, and those who have started treatment less than 12 months before joining. Participants will be followed for up to 5 years. Doctors will decide how often participants visit based on clinical judgment and drug labeling. Data will be collected at multiple time points, including 1, 2, 3, 6, 12, 24, 36, 48, and 60 months. During the study, researchers will monitor serious adverse events, including heart failure and liver damage related to the drug. They will also track reasons for stopping treatment, leaving the study, or taking more of the drug than prescribed. Participants remain under their own doctors care, and health data from regular visits will be collected throughout the study period.

CONDITIONS

Brief Title

A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own Doctors

Who Can Participate

Age: 16Years +

All Genders

Eligibility Criteria

You may qualify if you...

Documented diagnosis of Friedreich's Ataxia confirmed by genetic testing
Participants aged 16 years and older at the start of omaveloxolone treatment
For omaveloxolone-naive cohort: starting omaveloxolone treatment as per approved label during study enrollment
For omaveloxolone-non-naive cohort: started omaveloxolone treatment less than 12 months before enrollment
No treatment interruption of more than 60 days prior to enrollment
Actively receiving omaveloxolone treatment at enrollment
Treating physician is the study site principal investigator or sub-investigator
Study site can provide required baseline data through medical records or the UNIFAI database
Enrolled in the UNIFAI study before starting omaveloxolone treatment

You will not qualify if you...

Received omaveloxolone off-label at any time
Previously participated in a clinical trial of omaveloxolone
Participating in a blinded interventional trial at enrollment; can join other trials after baseline data collection
Other protocol-defined exclusion criteria may apply

Research Team

Study Director

Global Biogen Clinical Trial Center

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