EUCTR2007-001646-40-FRActive, not recruitingPhase 1
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
Santhera Pharmaceuticals (Switzerland) Ltd0 sites204 target enrollmentStarted: August 21, 2008Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 204
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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? 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) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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
- •Parallel participation in another clinical drug trial
- •Pregnancy or breast-feeding
- •Abuse of drugs or alcohol
Investigators
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