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

• Status: Terminated
• Trial end date: 2020-10-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Completion of the SIDEROS study at Visit 8/ Week 78

2. Signed and dated Informed Consent Form for SIDEROS-E

Exclusion Criteria:

1. Patients who discontinued SIDEROS study prematurely (i.e. did not attend all visits from V1 to V8)

2. Safety, tolerability or other issues arising during the course of the SIDEROS study which in the opinion of the Investigator may put the patient at significant risk or may interfere significantly with the patient's participation in the SIDEROS-E study

3. Use of any investigational drug other than the study medication