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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS1000000327 | Other Identifier | EU PAS number |
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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:
This study will be done as follows:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omaveloxolone | Participants 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omaveloxolone | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 years |
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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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Contact | 866-633-4636 | clinicaltrials@biogen.com | |
| Global Biogen Clinical Trial Center | Contact | clinicaltrials@biogen.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidera | Recruiting | Morrisville | North Carolina | 27560 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Number of Participants With Gestational Diabetes | Up to 9 months |
| Number of Participants With Pre-eclampsia | Up to 9 months |
| Number of Fetal Loss | A fetal loss that occurs for any reason at any time during pregnancy will be reported. | Up to 9 months |
| 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. | Up to 9 months |
| 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). | Up to 9 months |
| 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. | Up to 9 months |
| 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. | Up to 9 months |
| Number of Preterm Births | Preterm birth refers to a live birth at or before 37 weeks of gestation. | Up to 9 months |
| 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. | Up to 9 months |
| Number of Neonatal Deaths | Neonatal death refers to the death of a live-born infant within the first 28 days of life. | Within 28 days postdelivery |
| Number of Infant Deaths | Infant death refers to the death of a live-born infant within the first year of life. | Up to approximately 1 year |
| 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). | Up to approximately 1 year |
| 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. | Up to 1 year |
| 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. | Up to 1 year |
| ID | Term |
|---|---|
| D005621 | Friedreich Ataxia |
| ID | Term |
|---|---|
| D013132 | Spinocerebellar Degenerations |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000589490 | omaveloxolone |
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