Status:
COMPLETED
A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients
Lead Sponsor:
Santhera Pharmaceuticals
Conditions:
Friedreich's Ataxia
Eligibility:
All Genders
8+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in 12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised placebo-control...
Detailed Description
Idebenone, a short-chain analogue of Co-enzyme Q10 (CoQ10), has the potential to moderate underlying causes of Friedreich's Ataxia through its antioxidant activity and its role as an electron carrier ...
Eligibility Criteria
Inclusion
- 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, including swallowing the medication
- Negative urine pregnancy test at screening and at baseline (women of childbearing potential)
Exclusion
- Treatment with idebenone or Coenzyme Q10 within the past 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00905268
Start Date
April 1 2006
End Date
January 1 2010
Last Update
June 27 2016
Active Locations (13)
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1
Universitätsklinik Innsbruck
Innsbruck, Austria, 6020
2
Hôpital Erasme - Université Libre de Bruxelles
Brussels, Belgium, 1070
3
Hôpital de la Salpêtrière - INSERM U679, Neurologie et Thérapeutique expérimentale
Paris, France, 75651
4
HELIOS Klinikum BerlinBuch
Berlin, Germany, 13125