NCT00758225

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

A Phase II Open-label Extension Study to Obtain Long-term Safety, Tolerability and Efficacy Data of Idebenone in the Treatment of Duchenne Muscular Dystrophy - Extension to Study SNT-II-001

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	Idebenone	Patients ≤ 45 kg: 450 mg/day (1 tablet 3 times a day) Patients \> 45 kg: 900 mg/day (2 tablets 3 times a day)

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-09-25
• Last updated: 2011-06-01

Locations

1 site across 1 country: Belgium