ClinicalTrials.gov record NCT06628687
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
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study collects health information from women with Friedreich Ataxia who took omaveloxolone (BIIB141/SKYCLARYS) during pregnancy and/or while breastfeeding. Researchers will use routine medical records and study visits to follow mothers and their babies for up to 1 year after birth; the overall program is planned to run at least 10 years. The study includes both prospective and retrospective enrollments; retrospective participants are not included in the analysis population.
What it is studying. The study is trying to learn whether exposure to omaveloxolone during pregnancy or lactation is associated with pregnancy outcomes and infant health in the first year of life. The primary focus is counting major congenital malformations; secondary outcomes include minor malformations, pregnancy complications (for example, gestational diabetes and pre-eclampsia), fetal loss and stillbirth, preterm birth and small-for-gestational-age, live birth outcomes, infant growth and developmental milestones, hospitalizations, and serious or opportunistic infections.
What the researchers hope to learn. To describe and quantify pregnancy and infant outcomes after maternal exposure to omaveloxolone, including numbers of major and minor congenital malformations and various pregnancy and infant complications through the infant's first year of life.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will have taken BIIB141 at any time during pregnancy and/or while breastfeeding or pumping up through the first year after delivery. Participants can join this study on their own or they may be enrolled by their regular doctors. This study is also known as the "SKYCLARYS (Omaveloxolone) Pregnancy and Lactation Surveillance Program." The main objective of this study is to learn more about how BIIB141 may affect pregnancy, as well as any effects on the health of the mother and of the baby during its first year of life. The main question researchers want to answer in this study is: · Does taking BIIB141 during pregnancy or breastfeeding lead to any major birth defects? Researchers will also learn more about:
- Does taking BIIB141 during pregnancy or breastfeeding lead to any minor birth defects?
- Does taking BIIB141 during pregnancy or breastfeeding affect the following:
- Gestational diabetes, a disease that can happen during pregnancy that affects how your body uses sugar
- Pre-eclampsia, a pregnancy-related high blood pressure disease
- Unborn baby being small for its expected age (usually in weeks)
- Loss of an unborn baby
- Live birth
- Premature birth
- Loss of a newborn
- Growth or developmental delays in the baby
- Serious illness in the baby resulting in hospitalization
- Serious infections in the baby, or ones in babies with a weakened immune system
This study will be done as follows:
- Participants will join the study after signing an informed consent form, also known as an ICF.
- During the study, health information from the participants' regular visits to their doctor will be collected based on whether participant joined the study while pregnant or after the baby is born.
- Each participant will be in the study for up to 1 year after the birth of their child, unless they decide to leave early. Overall, this study is expected to last at least 10 years.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Omaveloxolone
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
The objective is to conduct a worldwide descriptive study to collect prospective and retrospective data in women exposed to omaveloxolone during pregnancy and/or lactation to assess risk associated with pregnancy, the maternal complications, and adverse effects on the developing fetus, neonate, and infant (through at least the first year of life) in the post-marketing setting.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
You would sign an informed consent form and allow the study to collect health information from your routine medical visits and records about your pregnancy, delivery, and your baby's health. Data may be collected prospectively (during pregnancy and up to 1 year after birth) or retrospectively (after the fact); retrospective records will be handled separately. The study is observational and collects existing medical information rather than assigning new treatments. Each participant's follow-up is up to 1 year after the child's birth.
How the study is structured. A prospective and retrospective observational cohort (post-marketing surveillance). The study collects health information from participants' routine care and study records without changing medical treatment. Women exposed to omaveloxolone during pregnancy or lactation may be enrolled before or after pregnancy outcome; prospective and retrospective enrollments are collected, but retrospective participants are not included in the analysis population. Each mother–child pair is followed for up to 1 year after birth; the program is planned to continue for at least 10 years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Friedreich ataxia
Important dates
- Study start
- Oct 26, 2026 (estimated)
- Primary completion
- Apr 30, 2035 (estimated)
- Study completion
- Apr 30, 2035 (estimated)
- Target enrollment
- 10 participants (estimated)
- Last updated on registry
- Jul 10, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Biogen
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- US Biogen Clinical Trial Center 📞 866-633-4636 ✉ clinicaltrials@biogen.com
- Global Biogen Clinical Trial Center ✉ clinicaltrials@biogen.com
Participating sites (1)
- EvideraRecruiting
Morrisville, North Carolina, 27560 · United States
- · 919-270-6678
- Ronna Chan
Terms used on this page · explanations by MedicalUpdates.ai
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Key Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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