Friedreich Ataxia Trial, Recruiting NCT06623890 Sponsor: Biogen Condition: Friedreich Ataxia
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Friedreich Ataxia Trial, Recruiting

NCT06623890
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Friedreich's Ataxia (FA), confirmed through genetic testing.
  • You are 16 years old or older when you start taking the medication omaveloxolone.
  • (If you have never taken omaveloxolone before) You are starting omaveloxolone as an approved treatment at the same time as joining this study.
  • (If you have already started omaveloxolone) You began taking omaveloxolone less than 12 months before joining this study.
  • (If you have already started omaveloxolone) You have been taking omaveloxolone continuously, with no break longer than 60 days.
  • (If you have already started omaveloxolone) You are currently still taking omaveloxolone at the time you enroll.
  • (If you have already started omaveloxolone) Your treating doctor is directly involved in running this study at the trial site.
  • (If you have already started omaveloxolone) The trial site is able to provide the required background health information about you from medical records or other approved sources.
  • (If you have already started omaveloxolone) You were enrolled in a related study called UNIFAI before you started taking omaveloxolone.

Who may not be able to join:

  • You have ever been prescribed omaveloxolone in a way that was not officially approved (off-label use).
  • You have previously taken part in a clinical trial specifically testing omaveloxolone.
  • You are currently taking part in another clinical trial where neither you nor the doctors know which treatment you are receiving (a "blinded" trial) at the time you enroll.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Medical Director, Biogen

Phone: 866-633-4636

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
12 December 2024
Est. completion
1 October 2029

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇺🇸 United States

Primary endpoints

Omaveloxolone Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs); Omaveloxolone Non-Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs); Omaveloxolone Naive Cohort: Number of Participants With DILI and CHF AEs; Omaveloxolone Non-Naive Cohort: Number of Participants With DILI and CHF AE

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov