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Observational Study of Omaveloxolone (BIIB141) for Friedreich's Ataxia

This study, called NCT06623890, is looking at the long-term safety of omaveloxolone (also known as BIIB141 or SKYCLARYS®) in people with Friedreich's Ataxia (FA). Omaveloxolone is a drug that doctors can already prescribe. This is an "observational" study, meaning researchers will collect health information from participants without changing their medical care. The main goal is to understand how safe omaveloxolone is over time, especially looking for serious side effects like liver injury or heart failure. You can join if you are 16 years or older, have a confirmed diagnosis of FA through genetic testing, and are either starting omaveloxolone or already taking it. The study aims to enroll 300 participants.

Study design
This is an observational study that will follow 300 participants. It collects health information without changing participants' medical care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to monitor for serious side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06623890

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

Recruiting
Not specifiedAges 16+Observational
Biogen
~300 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Omaveloxolone

At a glance

Recruiting sites
5 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Omaveloxolone Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Measured over From the start of the treatment up to end of the study (up to 5 years)
+3 more outcomes measured

Conditions

Friedreich Ataxia

Explore related trials

Friedreich Ataxia

NCT06623890

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Center for hereditary ataxias, Motol

    Motol, Prague, Czechiastudy coordinator listed

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Fondazione I.R.C.C.S. Istituto Neurologico C. Besta

    Milan, Italystudy coordinator listed

    Not yet recruiting

  • HUB-Hôpital Erasme

    Brussels, Belgiumstudy coordinator listed

    Not yet recruiting

  • Klinikum der Universität München

    Munich, Germanystudy coordinator listed

    Not yet recruiting

  • Medizinische Universität Innsbruck

    Innsbruck, Austriastudy coordinator listed

    Recruiting

  • Ospedale Pediatrico Bambino Gesu

    Rome, Italystudy coordinator listed

    Not yet recruiting

  • Scientific Institute, IRCCS E. Medea

    Conegliano, Italystudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Biogen

Who to contact

Study Director
[email protected]
866-633-4636
Email the study team

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Eligibility criteria

Inclusion

Documented diagnosis of FA, including confirmation via genetic testing.
Participants aged 16 years and older at initiation of omaveloxolone treatment.
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

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.

What this trial measures

  • Omaveloxolone Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)From the start of the treatment up to end of the study (up to 5 years)
  • Omaveloxolone Non-Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)From enrolment in the current study up to end of the study (up to 5 years)
  • Omaveloxolone Naive Cohort: Number of Participants With DILI and CHF AEsFrom the start of the treatment up to end of the study (up to 5 years)
  • Omaveloxolone Non-Naive Cohort: Number of Participants With DILI and CHF AEFrom enrolment in the current study up to end of the study (up to 5 years)