Trial intelligence / Profile preview

Long-term real-world safety study of Skyclarys in Friedreich's ataxia

NL-OMON61239Phase 4Not yet recruiting

Sponsor
Biogen
Start
Apr 2027
Modality
Small Molecules
Countries
1
01

Overview

Phase 4, open-label trial of omaveloxolone in Friedreich ataxia (FA) (2 cohorts), sponsored by Biogen. Primary endpoints: Description and incidence of drug-induced liver injury adverse events, Description and incidence of congestive heart failure adverse events and 1 more. Planned start Apr 2027; status: not yet recruiting.

02

Drugs

omaveloxolone
03

Conditions

Friedreich ataxia (FA)

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