Actively Recruiting
A Post-marketing Observational Study to Assess Pregnancy and Infant Risks Associated With Omaveloxolone Exposure in Individuals With Friedrich's Ataxia
Led by Biogen · Updated on 2025-06-26
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to understand the safety of BIIB141, also known as omaveloxolone or SKYCLARYS, in people with Friedrich's Ataxia who took this drug during pregnancy and/or while breastfeeding. The study aims to learn about the effects of BIIB141 on pregnancy and the health of both mother and baby during the baby's first year. The main focus is on whether taking BIIB141 during pregnancy or breastfeeding leads to major birth defects and other pregnancy-related complications. Participants include women with Friedrich's Ataxia who used omaveloxolone at any time from shortly before conception through pregnancy, and/or during breastfeeding up to one year after birth or until weaning. This study collects health information without changing medical care and is conducted over a period expected to last at least 10 years. Participants remain in the study for up to one year after their child's birth unless they withdraw earlier. During the study, researchers will collect health data from participants' regular doctor visits, focusing on pregnancy outcomes, complications such as gestational diabetes and pre-eclampsia, and the baby's health including growth, development, infections, hospitalizations, and survival. The main outcome measured is the number of major birth defects over up to 10 years, with other outcomes tracking minor birth defects and various maternal and infant health events. Participants provide consent before joining and can leave the study at any time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 16 years or older
- Exposure to omaveloxolone for Friedrich's Ataxia at any time during pregnancy (from 12 days before conception through pregnancy outcome)
- Exposure to omaveloxolone at any time during lactation (up to 1 year of infant age or until weaning)
You will not qualify if you...
- No exposure to omaveloxolone for Friedrich's Ataxia
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Up to 1 year after infant birth
Participants who were exposed to omaveloxolone during pregnancy and/or lactation are observed to assess maternal and infant health outcomes.
Regular check-ins to collect health information on mothers and infants up to 1 year
Duration - Up to 10 years
Extended observation of infants to monitor for congenital malformations and developmental outcomes.
Periodic assessments over up to 10 years to track health outcomes
Trial Site Locations
Total: 1 location
1
Evidera
Morrisville, North Carolina, United States, 27560
Actively Recruiting
Research Team
U
US Biogen Clinical Trial Center
G
Global Biogen Clinical Trial Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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