Observational Study of Omaveloxolone (SKYCLARYS) During Pregnancy and Breastfeeding for Friedreich's Ataxia
This is an observational study to learn more about the health of women with Friedreich's Ataxia (FA) who took omaveloxolone (also known as BIIB141 or SKYCLARYS) during pregnancy or while breastfeeding. Researchers will also gather information about the health of their babies. This study will collect health information without changing your medical care. The main goal is to understand how omaveloxolone might affect pregnancy, the mother, and the baby, especially looking at major birth defects. You can join if you're a woman aged 16 or older who has taken omaveloxolone for FA at any point during pregnancy or breastfeeding.
- Study design
- This is an observational study, meaning it collects health information without changing your medical care. It aims to enroll 10 women.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure major congenital malformations (birth defects) for up to 10 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
At a glance
Conditions
NCT06628687
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Evidera
Morrisville, North Carolinastudy coordinator listed
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
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of Major Congenital Malformations (MCMs)Up to 10 years
A MCM is defined as an abnormality of body structure or function that is present at birth; is of prenatal origin (i.e., birth defect); has significant medical, social, or cosmetic consequences for the affected participant; and typically requires medical intervention.