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Idebenone Extension Study in Friedreich's Ataxia
NCT00697073Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2008
- Primary completion
- May 2010
- Countries
- 1
- Sponsor
- Santhera Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- idebenone
- Conditions
- Friedreich's ataxia (FA)
01
Overview
Phase 3, open-label, single-arm trial of idebenone in Friedreich's ataxia (FA), sponsored by Santhera Pharmaceuticals. Primary endpoint: International Cooperative Ataxia Rating Scale at 12 months. Started Jul 2008; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
High dose Idebenone
Idebenone administered at high doses based on body weight.
03
Who it enrols
Patients with Friedreich's Ataxia who completed the core study SNT-III-002 (IONIA), weigh at least 25 kg, and have no significant liver abnormalities or history of substance abuse.
04
Endpoints
Primary
International Cooperative Ataxia Rating Scale
Secondary
Friedreich's Ataxia Rating Scale
Nature and Frequency of Adverse Events
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