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

Launched by BIOGEN · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the long-term safety of a medication called BIIB141, also known as omaveloxolone or SKYCLARYS®, for individuals with Friedreich's Ataxia (FA) who are starting this treatment for the first time. The study will observe participants to collect important health information without changing their usual medical care. Researchers want to find out if there are any serious health issues related to the drug, specifically looking for events that could be life-threatening or cause lasting problems, as well as any potential heart or liver issues.

To participate in this study, individuals must have a confirmed diagnosis of Friedreich's Ataxia and have never taken omaveloxolone before. Participants will be monitored over a period of up to five years, with regular visits to their doctor to check their health. The study will track how many participants experience serious health events or any side effects from the medication. It's important to note that those currently on omaveloxolone or involved in other specific clinical trials may not be eligible. This study aims to gather valuable information that could help improve treatment and safety for future patients with FA.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Documented diagnosis of FA, including confirmation via genetic testing.
• • 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
• Key Exclusion Criteria:
• • Received off-label prescription of omaveloxolone at any time.
• • 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.
• • Note: Other protocol-defined Inclusion/Exclusion criteria may apply.