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
Recruiting
Observational Study
Friedreich Ataxia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 300 (estimated)
- Sponsor
- Biogen · Industry
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About This Trial
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS®. This is a drug available for doctors to prescribe for people with Friedreich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will be found…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Documented diagnosis of FA, including confirmation via genetic testing.
* Participants aged 16 years and older at initiation of omaveloxolone treatment.
For the omaveloxolone-naive cohort
\- Initiating omaveloxolone treatment as per an approved label concurrent with enro…
Contacts