Efficacy of Omaveloxolone Treatment for Dysphagia in French Patients With Friedreich's Ataxia

Not yet recruitingOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

October 31, 2025

Conditions
Friedreich Ataxia
Interventions
DRUG

SKYCLARYS (omaveloxolone)

"Skyclarys is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 and over. Opaque capsule with RTA 408 printed in white ink on the light green body and 50 printed in white ink on the blue cap. Capsules (size 0) measure 21.7 ± 0.3 mm in length and the outer diameter of the cap is 7.64 ± 0.06 mm. Omaveloxolone should be initiated and monitored by physicians experienced in treating patients with patients with Friedreich's ataxia. The recommended dose is 150 mg omaveloxolone (3 x 50 mg capsules) once daily."

Trial Locations (1)

06000

CHU NICE, Nice

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nice

OTHER

NCT07013292 - Efficacy of Omaveloxolone Treatment for Dysphagia in French Patients With Friedreich's Ataxia | Biotech Hunter | Biotech Hunter