Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Male

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 functions, and skeletal muscle strength/function will be assessed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santhera Pharmaceuticals
• Treatments: Idebenone; Ubiquinone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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