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
NCT ID: NCT06623890
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
300 participants
OBSERVATIONAL
2024-12-12
2029-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 study research center to check on their health. This will be based on the doctor's own clinical judgment and what is recommended by the drug's label.
* Data from the participants' regular visits to their doctor will be collected at 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months.
* Each participant will be in the study for up to 5 years.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old
NCT06054893
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
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
NCT06628687
A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia
NCT02255435
A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
NCT07149415
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Omaveloxolone Naive Cohort
Participants with FA who will initiate omaveloxolone treatment per its approved label will be followed prospectively for up to 5 years.
Omaveloxolone
Administered as specified in the treatment arm.
Omaveloxolone Non-Naive Cohort
Participants with FA who initiated omaveloxolone treatment as per the approved label less than 12 months prior to enrollment in this study will be analyzed retrospectively (baseline data) followed by prospective analysis (post-baseline data) for up to 5 years.
Omaveloxolone
Administered as specified in the treatment arm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Omaveloxolone
Administered as specified in the treatment arm.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA Neurology
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medizinische Universität Innsbruck
Innsbruck, , Austria
HUB-Hôpital Erasme
Brussels, , Belgium
Center for hereditary ataxias, Motol
Motol, Prague, Czechia
Universitätsklinikum Tübingen
Tübingen, Baden-Würtemberg, Germany
University Hospital Aachen
Aachen, , Germany
Klinikum der Universität München
Munich, , Germany
Scientific Institute, IRCCS E. Medea
Conegliano, , Italy
Fondazione I.R.C.C.S. Istituto Neurologico C. Besta
Milan, , Italy
Ospedale Pediatrico Bambino Gesu
Rome, , Italy
Stichting Radboud universitair medisch centrum
Nijmegen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUPAS1000000196
Identifier Type: OTHER
Identifier Source: secondary_id
296FA401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.