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-BE
- Lead Sponsor
- Santhera Pharmaceuticals (Switzerland) Limited
- 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 baseline
· Patients with body weight = 25kg
· Patients who in the opinion of the investigator are able to comply with the requirements of the study
· Negative urine pregnancy test at screening and at Visit 1/Day 0/Baseline (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 Coenzyme Q 10 within 1 month
· Pregnancy 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