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NCT06623890 · ClinicalTrials.gov registry record
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
A clinical trial of Friedreich Ataxia, sponsored by Biogen.
- Recruiting
- Registry status
- 300
- Enrollment target
- 14
- Study locations
NCT06623890 is a study of Friedreich Ataxia that is actively recruiting participants, run by Biogen. The registered enrollment target is 300 participants, below the 428-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (30% lower). The trial reports 14 study locations across 7 states.
The verdict
NCT06623890, a study of Friedreich Ataxia, is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 14
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 428-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (30% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
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.
NCT06623890 reports 14 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Colorado.
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.
What interventions are being tested in trial NCT06623890?
The interventions under investigation include: Omaveloxolone (DRUG).
Who is sponsoring clinical trial NCT06623890?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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