What is BIIB141 (omaveloxolone) studying for Friedrich's Ataxia during pregnancy and breastfeeding?

This study is evaluating the safety of BIIB141 when taken by people with Friedrich's Ataxia during pregnancy and breastfeeding. Researchers want to understand if the drug leads to any birth defects or health issues for the mother and baby. The study is sponsored by Biogen and collects health information without changing medical care.

Who may be eligible for this Friedrich's Ataxia clinical trial?

Women aged 16 years or older with Friedrich's Ataxia who have taken omaveloxolone during pregnancy or breastfeeding may be eligible. The study only includes females exposed to the drug during these times. Please review eligibility criteria for more details.

Is there any cost to participate in this Friedrich's Ataxia clinical trial?

Study-related care, including data collection and trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 16Years +

FEMALE

ID06628687

Observational Study on the Safety of Omaveloxolone BIIB141 During Pregnancy and Breastfeeding in Women With Friedrichs Ataxia and Effects on Their Babies Health

Led by Biogen · Updated on 2026-07-10

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting an observational study to understand the safety of BIIB141, also called omaveloxolone or SKYCLARYS, in people with Friedrichs Ataxia FA who took this drug during pregnancy andor breastfeeding. The study aims to assess any risks to the mother and baby, including major and minor birth defects, maternal complications, and health effects on the baby up to one year after birth. This research will collect health information without changing participants regular medical care. Participants include women with FA exposed to omaveloxolone anytime from shortly before conception through pregnancy and breastfeeding up to one year after their baby is born or until weaning. The study involves collecting both new and past data from participants routine healthcare visits. The study will last at least 10 years to gather comprehensive information about pregnancy outcomes and infant health. During the study, researchers will monitor various outcomes such as the number of major and minor birth defects, gestational diabetes, pre-eclampsia, fetal loss, premature birth, infant growth and development, hospitalizations, and infections. Participants will join after consenting and remain in the study for up to one year after their childs birth unless they choose to leave earlier. The study collects data from routine care visits and does not involve administering any treatment.

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

Age: 16Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Exposure to omaveloxolone for Friedrich's Ataxia 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).

You will not qualify if you...

Not having exposure to omaveloxolone for Friedrich's Ataxia.

Research Team

US Biogen Clinical Trial Center

Global Biogen Clinical Trial Center

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