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Friedreich AtaxiaNCT06628687

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

An observational study of Friedreich Ataxia, run by Biogen at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Friedreich Ataxia
What is being tested?
Omaveloxolone
How many people
10 participants
Where
1 siteUnited States
Study dates
26 Oct 2026to 30 Apr 2035
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population will include participants with FA who were exposed to omaveloxolone at any time during pregnancy and/or lactation. Participants will be enrolled prospectively and retrospectively. Women who enroll prior to pregnancy outcome, and/or prior to start of breastfeeding will be enrolled as prospective participants. Women who enroll after the pregnancy has occurred and/or following the start of breastfeeding will be enrolled as retrospective participants. Retrospective participants will not be included in the analysis population. For prospective and retrospective participants exposed during lactation only, data will be reported separately from pregnancy exposure cases.

Who may be able to join

  • 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).

Who cannot join

  • Not having exposure to omaveloxolone for FA.
  • Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

US Biogen Clinical Trial Center contact

866-633-4636

clinicaltrials@biogen.com

Global Biogen Clinical Trial Center contact

clinicaltrials@biogen.com

United States1 site, 1 recruiting

  • Evidera

    Morrisville, North Carolina, 27560

    919-270-6678

    Ronna Chan

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read more

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.
Read the detailed description

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.

Being tested
Omaveloxolone
Medical subject headings
Friedreich Ataxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmaveloxoloneDrug

    Also called SKYCLARYS, BIIB141, RTA 408

    Administered as specified in the treatment arm.

Study groups in NCT06628687
Study groupRoleWhat they receive
OmaveloxoloneParticipants with FA who were exposed to omaveloxolone at any time during pregnancy (from 12 days prior to conception through the end of pregnancy outcome), and/or at any time during lactation (up to 1 year of infant age or weaning, whichever comes first).
Receives: Drug: Omaveloxolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Major Congenital Malformations (MCMs)

    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.

    Measured: Up to 10 years

Secondary outcomes (15)

  1. Number of Minor Congenital Malformations

    Minor congenital malformations include an anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected participant.

    Measured: Up to 10 years

  2. Number of Participants With Gestational Diabetes

    Measured: Up to 9 months

  3. Number of Participants With Pre-eclampsia

    Measured: Up to 9 months

  4. Number of Fetal Loss

    A fetal loss that occurs for any reason at any time during pregnancy will be reported.

    Measured: Up to 9 months

  5. Number of Spontaneous Abortions

    Spontaneous abortion refers to an involuntary fetal loss or the expulsion of the products of conception occurring prior to 20 gestational weeks.

    Measured: Up to 9 months

  6. Number of Stillbirths

    Still birth refers to an involuntary fetal loss occurring at or after 20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥ 350 grams (g).

    Measured: Up to 9 months

  7. Number of Elective or Therapeutic Abortion

    Elective or therapeutic abortion refers to a voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to fetal abnormalities.

    Measured: Up to 9 months

  8. Number of Live Births

    Live birth refers to the birth of a living fetus after 20 weeks of gestation or, if gestational age is unknown, weighing ≥ 350 g.

    Measured: Up to 9 months

  9. Number of Preterm Births

    Preterm birth refers to a live birth at or before 37 weeks of gestation.

    Measured: Up to 9 months

  10. Number of Small for Gestational Age (SGA)

    SGA is defined as birth weight less than 10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.

    Measured: Up to 9 months

  11. Number of Neonatal Deaths

    Neonatal death refers to the death of a live-born infant within the first 28 days of life.

    Measured: Within 28 days postdelivery

  12. Number of Infant Deaths

    Infant death refers to the death of a live-born infant within the first year of life.

    Measured: Up to approximately 1 year

  13. Number of Infants with Abnormal Postnatal Growth and Development

    Infant growth measurements will be used to estimate gender-specific weight-for-length, head circumference-for-age, length-for-age, and weight-for-age percentiles. Developmental milestones (i.e., social/emotional, language/communication, neurocognitive, movement/physical development) will be evaluated to determine results of infant status (i.e., infants who are failing to achieve at least one milestone in any category will be considered developmentally delayed in that category).

    Measured: Up to approximately 1 year

  14. Number of Infant Hospitalization due to Serious Illness

    Infant hospital visit due to a serious (that is, results in significant disability, incapacity, or death; is life-threatening; requires inpatient or prolonged hospitalization; or is considered medically important) illness will be reported.

    Measured: Up to 1 year

  15. Number of Infant Serious or Opportunistic Infections

    Infections that occur within an infant's first year of life and is either opportunistic (i.e., occurs more often or is more severe in people with weakened immune systems than in people with healthy immune systems) or serious (that is, results in significant disability, incapacity, or death; is life-threatening; requires inpatient or prolonged hospitalization; or is considered medically important) will be reported.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start26 Oct 2026 (estimated)
  3. Primary completion30 Apr 2035 (estimated)
  4. Study completion30 Apr 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06628687
Sponsor's protocol ID
296FA402
Other IDs
EUPAS1000000327
Status last verified
Jul 2026
First submitted
30 Sep 2024
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

An observational study of Friedreich Ataxia, run by Biogen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Major Congenital Malformations (MCMs) (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06628687.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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