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
Launched by BIOGEN · Oct 4, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The SKYCLARYS® (Omaveloxolone) Pregnancy and Lactation Surveillance Program is a clinical trial designed to understand the effects of the medication omaveloxolone on women with Friedreich's Ataxia (FA) during pregnancy and while breastfeeding. The study aims to find out if using this medication could lead to any risks for the mother, as well as any potential issues for the baby during pregnancy and after birth.
To participate in the trial, women must have taken at least one dose of omaveloxolone at any time during their pregnancy or while breastfeeding. The study is currently looking for female participants who are between the ages of 18 and 45. If you are eligible and decide to join, you can expect to provide information about your experience with the medication and any effects it may have had on your pregnancy or breastfeeding. This important research will help provide valuable information to healthcare providers and future patients regarding the safety of omaveloxolone for expectant and new mothers with Friedreich's Ataxia.
Gender
FEMALE
Eligibility 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.
About Biogen
Biogen is a leading biotechnology company dedicated to discovering, developing, and delivering innovative therapies for neurological and neurodegenerative diseases. With a strong focus on research and development, Biogen leverages advanced science and cutting-edge technology to address the unmet needs of patients suffering from conditions such as multiple sclerosis, Alzheimer's disease, and spinal muscular atrophy. The company is committed to advancing the understanding of the underlying biology of these diseases and is actively engaged in clinical trials to evaluate new treatment options, aiming to improve patient outcomes and enhance quality of life. With a global presence and a robust pipeline of therapies, Biogen is at the forefront of innovation in the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Morrisville, North Carolina, United States
Patients applied
Trial Officials
Medical Director
Study Director
Biogen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported