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Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E) — SIDEROS-E  

Duchenne Muscular Dystrophy Clinical Trial

Official title:
A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study

Clinical Trial Summary

The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.

Clinical Trial Description

The study is an open-label, single-group, multi-center extension study in patients with DMD receiving glucocorticoid steroids who participated in the SIDEROS study and who meet all the inclusion criteria and none of the exclusion criteria for this extension study. The study consists of 4 study visits scheduled every 6 months (Visit 1/Baseline, Visit 2/Week 26, Visit 3/ Week 52 and Visit 4/ Week 78), and a follow-up visit 4 weeks after treatment discontinuation. Visit 8/Week 78 in SIDEROS study is also SIDEROS-E Visit 1/Baseline. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03603288
Study type Interventional
Source Santhera Pharmaceuticals
Contact
Status Terminated
Phase Phase 3
Start date July 4, 2018
Completion date November 25, 2020
View Details
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