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A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old (BRAVE)
NCT06953583 · View on ClinicalTrials.gov ↗
Study Summary
In this study, researchers will learn more about the effects and safety of BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedreich's Ataxia (FA) who are at least 16 years old. But, it is not yet available for children and teens with FA who are younger than 16 years old. The main objective of this study is to learn how BIIB141 works in the body and about its safety in children and teens who are 2 to 15 years old. The main questions researchers want to answer in this study are: * How does BIIB141 affect the participants' FA symptoms balance and stability? * How many participants have medical problems during the study? * Are there any changes in the participants' overall health during the study? * Are there any changes in the participants' heart health? * Are there any changes in how the participants move through puberty? Puberty is the time in someone's life when their body changes from a child to an adult. Researchers will also learn more about: \- How the body processes BIIB141 in children and teens This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center. * There are 2 parts in this study. During Part 1, participants will take either BIIB141 or a placebo once a day. * In Part 1, participants will take BIIB141 or the placebo in a study research center on Day 1, and then at in-person visits at Week 4, Week 12, Week 26, and Week 52. On all other days, they will take BIIB141 or the placebo at home. Part 1 lasts up to 52 weeks. * During Part 2, participants from Part 1 will either continue taking BIIB141 or start it if they were taking the placebo. Part 2 will last up to 104 weeks. * In Part 1, participants will have up to 10 visits to their study research center and a phone call at Week 2. In Part 2, participan
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Omaveloxolone
Study Locations (20)
Other
- Universitätsklinikum Innsbruck — Innsbruck
- Rigshospitalet - Juliane Marie Centret (JMC) Copenhagen — Copenhagen
- AP-HP - Hôpital Armand Trousseau — Paris
- UKGM - Universitätsklinikum Giessen und Marburg GmbH - Standort Gießen — Giessen
Florida
- Norman Fixel Institute for Neurological Diseases UF Health — Gainesville
- USF Health Morsani College of Medicine Department of Neurology — Tampa
São Paulo
- University of Campinas (UNICAMP) School of Medical Sciences — Campinas
- PSEG Centro de Pesquisa Clinica — São Paulo
Quebec
- McGill University — Montreal
- CHU de Quebec -Universite Laval — Québec
California
- UCLA Neurology Outpatient Clinic at Westwood — Los Angeles
Pennsylvania
- Children's Hospital of Philadelphia - Buerger Center for Advanced Pediatric Care - PIN — Philadelphia
Tennessee
- St. Jude Children's Research Hospital - PIN — Memphis
Virginia
- CHKD's Health Center - South Campus - PIN — Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2025-06-09 |
| Est. Completion | 2029-11-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06953583
The ClinicalTrials.gov registry entry for NCT06953583 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 255 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Friedreich Ataxia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06953583 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Florida, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06953583 about?
NCT06953583 is a clinical study titled "A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old (BRAVE)". In this study, researchers will learn more about the effects and safety of BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedreich's Ataxia (FA) who are at least 16 years old. But, it is not yet available...
What is the current status of trial NCT06953583?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2025-06-09. Estimated completion is 2029-11-22.
What conditions does trial NCT06953583 study?
This clinical trial studies the following conditions: Friedreich Ataxia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06953583?
The interventions under investigation include: Placebo (DRUG), Omaveloxolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06953583?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06953583 being conducted?
This trial has 20 study locations across California, Florida, Pennsylvania, Tennessee, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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