Status:
COMPLETED
Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)
Lead Sponsor:
Santhera Pharmaceuticals
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
The scientific aim of the present extension study is to monitor long-term safety and tolerability of idebenone in patients with DMD. Furthermore, the long-term effect on respiratory, cardiac and motor...
Eligibility Criteria
Inclusion
- Completion of study SNT-II-001
- Body weight ≥ 25 kg
- Glucocorticosteroids and ACE-inhibitors are allowed, if on stable dosage within 2 months prior to inclusion
- Eligibility to participate in the present extension study as confirmed by the investigator
Exclusion
- Safety or tolerability issues arising during the course of SNT-II-001 which in the opinion of the investigator preclude further treatment with idebenone
- Clinically significant abnormalities of haematology or biochemistry
- Abuse of drugs or alcohol
- Use of coenzyme Q10 or idebenone within 30 days prior to inclusion
- Intake of any investigational drug within 30 days prior to inclusion
- Symptomatic heart failure
- Previous history of ventricular arrhythmias (other than isolated ventricular extrasystole); ventricular arrhythmias presented at baseline
- Known individual hypersensitivity to idebenone or to any of the excipients
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00758225
Start Date
September 1 2008
End Date
January 1 2011
Last Update
June 1 2011
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Belgium, 3000