Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santhera Pharmaceuticals
• Treatments: Idebenone; Ubiquinone

Criteria

Inclusion criteria:

• Friedreich's ataxia patients completing core study SNT-III-002 (NCT00537680) and presenting at Week 24 (Visit 5) of that study

• Body weight ≥ 25kg/55 lbs

• Negative urine pregnancy test

• Patients who in the opinion of the investigator are able to comply with the requirements of this study

Exclusion criteria:

• Adverse events during the course of SNT-III-002(NCT00537680)which in the opinion of the investigator are attributable to idebenone and preclude further treatment with idebenone

• Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine

• Treatment with coenzyme Q10, vitamin E (if taken at a dose 5 times above the daily requirement) or other sources of idebenone within the past month

• Parallel participation in another clinical drug trial

• Past or present history of abuse of drugs or alcohol

• Pregnancy or breast-feeding