Overview

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