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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

Recruitingn/aAges 16 Years - anyAllBiogen
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In plain words

What the trial is, and whether it could suit you

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 the

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 enrolling in this study. For the omaveloxolone-non-naive cohort * Initiated omaveloxolone treatment as per an approved label less than 12 months prior to enrollment in this study * Prior to enrollment, maintained omaveloxolone treatment with no discontinuation of more than 60 days * Actively on treatment at the time of enrollment in this study * Treating physician is the study site principal investigator or sub-investigator * Study site confirms ability to provide required baseline data through medical record review, UNIFAI database, or other site-collected data * Enrolled in the UNIFAI study prior to initiation of omaveloxolone treatment Key Exclusion Criteria: * Received off-label prescription of omaveloxolone at any time. * Previously enrolled in a clinical trial of omaveloxolone. * Participating in a blinded interventional trial at the time of enrollment in the study; participants may participate in other clinical trials after baseline data are collected. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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What it tests

  • Omaveloxolone
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Where

14 sites
UCLA Neurology
Los Angeles, United States
University of Colorado
Aurora, United States
University of Florida
Gainesville, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Medizinische Universität Innsbruck
Innsbruck, Austria
HUB-Hôpital Erasme
Brussels, Belgium
Center for hereditary ataxias, Motol
Motol, Czechia
Universitätsklinikum Tübingen
Tübingen, Germany

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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