Status:
COMPLETED
Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients
Lead Sponsor:
Santhera Pharmaceuticals
Conditions:
Friedreich's Ataxia
Eligibility:
All Genders
8-18 years
Phase:
PHASE3
Brief Summary
This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.
Detailed Description
The study involves 6 clinic visits.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Friedreich's ataxia patients completing core study SNT-III-002 (NCT00537680) and presenting at Week 24 (Visit 5) of that study
- Body weight ≥ 25kg/55 lbs
- Negative urine pregnancy test
- Patients who in the opinion of the investigator are able to comply with the requirements of this study
- Exclusion criteria:
- Adverse events during the course of SNT-III-002(NCT00537680)which in the opinion of the investigator are attributable to idebenone and preclude further treatment with idebenone
- Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
- Treatment with coenzyme Q10, vitamin E (if taken at a dose 5 times above the daily requirement) or other sources of idebenone within the past month
- Parallel participation in another clinical drug trial
- Past or present history of abuse of drugs or alcohol
- Pregnancy or breast-feeding
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00697073
Start Date
July 1 2008
End Date
May 1 2010
Last Update
July 11 2023
Active Locations (2)
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1
David Geffen School of Medicine, UCLA
Los Angeles, California, United States, 90095-1769
2
The Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104