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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
NCT06623890 · View on ClinicalTrials.gov ↗
Study Summary
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 s
Conditions Studied
Interventions
- DRUG Omaveloxolone
Study Locations (14)
Other
- Medizinische Universität Innsbruck — Innsbruck
- HUB-Hôpital Erasme — Brussels
- University Hospital Aachen — Aachen
- Klinikum der Universität München — Munich
- Scientific Institute, IRCCS E. Medea — Conegliano
- Fondazione I.R.C.C.S. Istituto Neurologico C. Besta — Milan
- Ospedale Pediatrico Bambino Gesu — Rome
- Stichting Radboud universitair medisch centrum — Nijmegen
California
- UCLA Neurology — Los Angeles
Colorado
- University of Colorado — Aurora
Florida
- University of Florida — Gainesville
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Prague
- Center for hereditary ataxias, Motol — Motol
Baden-Würtemberg
- Universitätsklinikum Tübingen — Tübingen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2029-10-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06623890
The ClinicalTrials.gov registry entry for NCT06623890 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 300 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 1 intervention — of which Omaveloxolone 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: NCT06623890 reports 14 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Colorado. 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 NCT06623890 about?
NCT06623890 is a clinical study titled "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". 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 abo...
What is the current status of trial NCT06623890?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2024-12-12. Estimated completion is 2029-10-01.
What conditions does trial NCT06623890 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 NCT06623890?
The interventions under investigation include: Omaveloxolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06623890?
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 NCT06623890 being conducted?
This trial has 14 study locations across California, Colorado, Florida, Pennsylvania, Prague. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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