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 - MICONOS EXTENSIO
- Conditions
- Friedrich's AtaxiaMedDRA version: 12.0Level: LLTClassification code 10017374Term: Friedreich's ataxia
- Registration Number
- EUCTR2007-001646-40-BE
- Lead Sponsor
- Santhera Pharmaceuticals (Switzerland) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 232
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method