A Phase III Open-Label, Single-Group, Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich*s Ataxia Patients

Phase 3

Completed

• Conditions: Friedreichs ataxia; 10010394; 10028396; 10010335

• Registration Number: NL-OMON32601
• Lead Sponsor: Santhera Pharmaceuticals (Switzerland) Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- Completion of 52 weeks in study SNT-III-001
- Body weight >= 25kg
- Negative urine pregnancy test
- Eligibility to participate in the present extension study as confirmed by the
investigator

Exclusion Criteria

- Safety or tolerability issues arising during the course of SNT-III-001 which in
the opinion of the investigator preclude further treatment with idebenone
- Clinically significant abnormalities of haematology or biochemistry including,
but not limited to, elevations greater than 1.5 times the upper limit of SGOT,
SGPT or creatinine
- Parallel participation in another clinical drug trial
- Pregnancy or breast-feeding
- Abuse of drugs or alcohol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Measures of safety and tolerability<br /><br>- nature and frequency of AEs<br /><br>- haematological and biochemical parameters<br /><br>- physical examinations and vital signs<br /><br>- ECGs<br /><br>Absolute change in scores from baseline to Month 12, and to Month 24 assessed<br /><br>by:<br /><br>- International Cooperative Ataxia Rating Scale (ICARS)<br /><br>- Friedreich*s Ataxia Rating Scale (FARS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not Applicable</p><br>