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

2025-523881-26-00 · tracked via the Priya Life Science EU tracker

Sponsor

Fakultni Nemocnice V Motole

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Nervous System Diseases

Decision date

30/03/2026

Enrollment target

Sites

Czechia, Poland

Condition studied

Friedreich's ataxia

Investigational medicinal product(s)

Skyclarys 50 mg hard capsules

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

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.

Endpoint detail

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.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523881-26-00 on CTIS ↗ ← All trials in the EU