Health effects of omaveloxolone taken during pregnancy or breastfeeding in people with Friedreich's Ataxia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a worldwide, non‑interventional surveillance program collecting both prospective and retrospective data on women with Friedreich's Ataxia who were exposed to omaveloxolone during pregnancy and/or lactation. The study gathers medical records and patient-reported information about maternal complications, pregnancy outcomes, and infant health through at least the first year of life. Participants can enroll themselves or be referred by their treating clinicians, and no changes to routine medical care are required. Data are collected in the post‑marketing setting to describe potential risks associated with exposure to omaveloxolone in pregnancy and breastfeeding.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

\- Exposure to omaveloxolone for FA at any time during pregnancy (from 12 days prior to conception to pregnancy outcome) and/or at any time during lactation (up to 1 year of infant age or weaning, whichever comes first).

Key Exclusion Criteria:

\- Not having exposure to omaveloxolone for FA.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it's running

• Evidera
  Morrisville, North Carolina, United States Recruiting

Study contacts

• Study coordinator: US Biogen Clinical Trial Center
• Email: clinicaltrials@biogen.com
• Phone: 866-633-4636

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nomlabofusp by injection for Friedreich's Ataxia: efficacy and safety

  This study tests whether subcutaneous nomlabofusp helps adults and children with Friedreich's Ataxia compared with placebo.

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• LX2006 Gene Therapy for Friedreich Ataxia Cardiomyopathy (FA-CM)

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  Recruiting Phase 2 Lexeo Therapeutics · Tampa, Florida · NCT07721025

• Nerve ultrasound in people with Friedreich ataxia

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• Omaveloxolone for swallowing problems in French people with Friedreich's ataxia

  This project will test whether omaveloxolone (SKYCLARYS) improves swallowing in French people aged 16 and older with genetically confirmed Friedreich's ataxia who have used the drug for at least six months.

  Recruiting Centre Hospitalier Universitaire de Nice · Nice, Alpes Maritimes · NCT07013292

• Testing DT-216P2 in patients with Friedreich's Ataxia

  This study is testing a new drug called DT-216P2 in adults with Friedreich's Ataxia to see how safe it is and how well it works in their bodies.

  Recruiting at 3 sites Phase 1/2 Design Therapeutics, Inc. · Sydney, New South Wales and 2 other locations · NCT06874010

• Clinical course of cardiomyopathy in people with Friedreich ataxia

  This study follows people with Friedreich ataxia who have cardiomyopathy to see how their heart disease changes over time and to identify who may later be eligible for a gene therapy study.

  Recruiting at 18 sites Lexeo Therapeutics · La Jolla, California and 18 other locations · NCT06865482

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.