Phase 3
Completed N=68
Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients
Source: ClinicalTrials.gov NCT00697073 ↗Enrolled (actual)
68
Serious AEs
5.9%
Results posted
Aug 2011
Primary outcomePrimary: Change in ICARS — 1.1 units on a scale
Summary
This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ICARS |
1.1 | — |
| SECONDARY FARS (Friedreich's Ataxia Rating Scale) |
2.3 | — |
| SECONDARY Nature of Adverse Events |
117; 97; 75 | — |
| SECONDARY Frequency/Number of Mild, Moderate, and Severe Adverse Events |
30; 32; 4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00697073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.