Identification of mitochondrial biomarkers reflecting omaveloxolone treatment (in FA patients)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523881-26-00

Enrollment

Registered

2026-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Friedreich's ataxia

Brief summary

Change in mitochondrial biomarkers (lipofuscin-like pigments, PINK1, ULK1, BNIP3L, TFEB, LC3, p62, GPX4, SLC7A11, and 4-HNE) from baseline to 6 and 12 months in patients with FA treated with omaveloxolone.

Detailed description

Between-group differences in mitochondrial biomarkers at the 6-month timepoint (treated FA patients vs. controls)., Correlation of biomarker changes with changes in mFARS, SARA, and ADL scores over time.

Interventions

DRUGSkyclarys 50 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in mitochondrial biomarkers (lipofuscin-like pigments, PINK1, ULK1, BNIP3L, TFEB, LC3, p62, GPX4, SLC7A11, and 4-HNE) from baseline to 6 and 12 months in patients with FA treated with omaveloxolone.	—

Secondary

Measure	Time frame
Between-group differences in mitochondrial biomarkers at the 6-month timepoint (treated FA patients vs. controls)., Correlation of biomarker changes with changes in mFARS, SARA, and ADL scores over time.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 31, 2026