A Phase III double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of Friedreich's Ataxia patients. - MICONOS
- Conditions
- Friedreich's AtaxiaMedDRA version: 12.0Level: LLTClassification code 10017374Term: Friedreich's ataxia
- Registration Number
- EUCTR2005-004083-22-AT
- Lead Sponsor
- Santhera Pharmaceuticals (Switzerland) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 232
•Documented diagnosis of FRDA with confirmed FRDA mutations
•Patients 8 years of age or older at time of enrolment
•Patient with body weight greater or equal to 25 kg
•Patients who in the opinion of the investigator are able to comply with the
requirements of the study
•Negative urine pregnancy test at screening (women of childbearing potential)
Are the trial subjects under 18? yes
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
•Treatment with idebenone or coenyzme Q within 1 month
•Pregnancy and/or breast-feeding
•Clinically significant abnormalities of clinical haematology or biochemistry
including, but not limited to, elevations greater than 1.5 times the upper
limit of normal of SGOT, SGPT or creatinine
•Past or present history of 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