Health effects of omaveloxolone taken during pregnancy or breastfeeding in people with Friedreich's Ataxia
A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications, and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation
See if taking BIIB141 (omaveloxolone) during pregnancy or while breastfeeding affects the health of people with Friedreich's Ataxia and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | Biogen Industry-sponsored |
| Locations | 1 site (Morrisville, North Carolina) |
| Trial ID | NCT06628687 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with Friedreich's Ataxia who took omaveloxolone at any time from shortly before conception through pregnancy and/or while breastfeeding up to one year postpartum.
Not a fit: People who never took omaveloxolone (including men and women unexposed during pregnancy or lactation) would not benefit from this surveillance program.
Why it matters
Potential benefit: If successful, the study could provide clearer safety information to help patients and doctors make informed treatment and breastfeeding decisions during pregnancy and postpartum.
How similar studies have performed: Pregnancy and lactation registries for other drugs have successfully identified safety signals and guided clinical counseling, but this is the first large post‑marketing surveillance focused on omaveloxolone exposure in pregnancy and breastfeeding.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Morrisville, North Carolina
- Evidera — Morrisville, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: US Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
- Phone: 866-633-4636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.