Condition: Friedreich Ataxia · Sponsor: Biogen
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 …
This description comes directly from the study's public registry record.
Study Director · 866-633-4636 · clinicaltrials@biogen.com
Global Biogen Clinical Trial Center · clinicaltrials@biogen.com
Always discuss trial participation with your own doctor first.
| UCLA Neurology | Los Angeles, California, United States | Not Yet Recruiting |
| University of Colorado | Aurora, Colorado, United States | Recruiting |
| University of Florida | Gainesville, Florida, United States | Not Yet Recruiting |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States | Recruiting |
| Medizinische Universität Innsbruck | Innsbruck, Austria | Recruiting |
| HUB-Hôpital Erasme | Brussels, Belgium | Not Yet Recruiting |
| Center for hereditary ataxias, Motol | Motol, Prague, Czechia | Recruiting |
| Universitätsklinikum Tübingen | Tübingen, Baden-Würtemberg, Germany | Recruiting |
| University Hospital Aachen | Aachen, Germany | Not Yet Recruiting |
| Klinikum der Universität München | Munich, Germany | Not Yet Recruiting |
| Scientific Institute, IRCCS E. Medea | Conegliano, Italy | Not Yet Recruiting |
| Fondazione I.R.C.C.S. Istituto Neurologico C. Besta | Milan, Italy | Not Yet Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06623890