A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich’s Ataxia Aged 2 to 15 Years Old

Description

Recruitment will be limited to the U.S. only as participants will be able to remain on Part 2 of the study until they turn 16 and can access commercially-available drug which is FDA approved for age 16 and above. The part 1 primary objective of the study is to evaluate the pharmacokinetics (PK) of omaveloxolone following administration of a single dose in 3 age cohorts (2 to <7 years, 7 to <12 years, and 12 to <16 years) and secondary objective is to evaluate safety and tolerability of drug. The part 2 primary objective is to evaluate long term safety and tolerability of omaveloxolone.