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)
Public ClinicalTrials.gov record NCT06953583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled Study (Part 1) and Open-Label Extension (Part 2) to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omaveloxolone (BIIB141) in Participants With Friedreich's Ataxia Aged 2 to < 16 Years
Study identification
- NCT ID
- NCT06953583
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Biogen
- Industry
- Enrollment
- 255 participants
Conditions and interventions
Conditions
Interventions
- Omaveloxolone Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 15 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 8, 2025
- Primary completion
- Nov 15, 2027
- Completion
- Nov 21, 2029
- Last update posted
- Mar 15, 2026
2025 – 2029
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Neurology Outpatient Clinic at Westwood | Los Angeles | California | 90095 | Not yet recruiting |
| Norman Fixel Institute for Neurological Diseases UF Health | Gainesville | Florida | 32610-3010 | Recruiting |
| USF Health Morsani College of Medicine Department of Neurology | Tampa | Florida | 33612 | Recruiting |
| Children's Hospital of Philadelphia - Buerger Center for Advanced Pediatric Care - PIN | Philadelphia | Pennsylvania | 19104 | Recruiting |
| St. Jude Children's Research Hospital - PIN | Memphis | Tennessee | 38105-3678 | Recruiting |
| CHKD's Health Center - South Campus - PIN | Norfolk | Virginia | 23507-1910 | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | 98105-3901 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06953583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06953583 live on ClinicalTrials.gov.