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
← catalyst calendarNCT06628687 · readout in 3,176 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
10estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-10-26 | estimated | When the study began enrolling |
| Primary completion | 2035-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2035-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Friedreich Ataxia
Intervention
- Drug: Omaveloxolone — also filed as SKYCLARYS, BIIB141, RTA 408
Primary outcome
what the primary-completion date above is the date OFNumber of Major Congenital Malformations (MCMs)
measured Up to 10 years
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