Status:
COMPLETED
Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)
Lead Sponsor:
Santhera Pharmaceuticals
Conditions:
Freidreich's Ataxia
Eligibility:
All Genders
9+ years
Phase:
PHASE3
Brief Summary
This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to...
Eligibility Criteria
Inclusion
- Completion of 52 weeks in study SNT-III-001
- Body weight ≥ 25 kg
- Negative urine pregnancy test
- Eligibility to participate in the present extension study as confirmed by investigator
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00993967
Start Date
June 1 2007
End Date
June 1 2012
Last Update
March 5 2018
Active Locations (11)
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1
Universitätsklinik Innsbruck
Innsbruck, Austria
2
Hôpital Erasme - Univeristé Libre de Bruxelles
Brussels, Belgium, 1070
3
Hôpital de la Salpétrière - INSERM U679, Neurologie et Thérapeutique expérimentale
Paris, France, 75651
4
HELIOS Klinikum Berlin
Berlin, Germany, 13125