Actively Recruiting
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
Led by Biogen · Updated on 2026-04-28
300
Participants Needed
14
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 using a group called the Friedreich's Ataxia Global Clinical Consortium (FA GCC) UNIFIED Natural History Study (UNIFAI). The FA-GCC is a group of study research centers that helps provide clinical care for FA patients and also helps researchers learn more about how FA affects patients over a long time. The main objective of this study is to collect safety information in participants with FA from UNIFAI. Some of the participants in this study will be prescribed BIIB141 for the first time by their own doctors. Some of the participants will have started taking BIIB141 after joining UNIFAI, but less than 12 months before joining this study. The main questions researchers want to answer in this study are: * How many participants had serious adverse events (SAEs)? An adverse event is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care. * How many participants had adverse events (AEs) related to heart failure or liver damage caused by the drug? Researchers will also learn more about : • Why and when participants stopped treatment, left the study, or took more of the drug than was prescribed This study will be done as follows: * Participants will be screened to check if they can join the study. * After joining the study, the participants who had never started BIIB141 treatment before must start it within 6 months. Otherwise, all participants will take BIIB141 throughout this study as prescribed by their own doctor. * During the study, each participant's doctor will decide how often the participant visits the study research center to check on their health. This will be based on the doctor's own clinical judgment and what is recommended by the drug's label. * Data from the participants' regular visits to their doctor will be collected at 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. * Each participant will be in the study for up to 5 years.
CONDITIONS
Official 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
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 according to approved label when joining the study
- For omaveloxolone-non-naive cohort: Started omaveloxolone less than 12 months before enrollment
- No treatment breaks longer than 60 days before enrollment
- Currently on omaveloxolone treatment at enrollment
- Treating physician is the study site principal or sub-investigator
- Study site can provide required baseline data from medical records, UNIFAI database, or other collected data
- 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 (may join other trials after baseline data collection)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
UCLA Neurology
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
University of Florida
Gainesville, Florida, United States, 32608
Not Yet Recruiting
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
6
HUB-Hôpital Erasme
Brussels, Belgium, 1070
Not Yet Recruiting
7
Center for hereditary ataxias, Motol
Motol, Prague, Czechia, 5, 15006
Actively Recruiting
8
Universitätsklinikum Tübingen
Tübingen, Baden-Würtemberg, Germany, 72076
Actively Recruiting
9
University Hospital Aachen
Aachen, Germany, 52074
Not Yet Recruiting
10
Klinikum der Universität München
Munich, Germany, 80336
Not Yet Recruiting
11
Scientific Institute, IRCCS E. Medea
Conegliano, Italy, 31015
Not Yet Recruiting
12
Fondazione I.R.C.C.S. Istituto Neurologico C. Besta
Milan, Italy, 20133
Not Yet Recruiting
13
Ospedale Pediatrico Bambino Gesu
Rome, Italy, 50
Not Yet Recruiting
14
Stichting Radboud universitair medisch centrum
Nijmegen, Netherlands, 6525
Not Yet Recruiting
Research Team
S
Study Director
CONTACT
G
Global Biogen Clinical Trial Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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