Trials / Terminated
TerminatedNCT03603288
Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- Santhera Pharmaceuticals · Industry
- Sex
- Male
- Age
- 11 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | idebenone 150 mg film-coated tablets | 900 mg idebenone/day |
Timeline
- Start date
- 2018-07-04
- Primary completion
- 2020-11-25
- Completion
- 2020-11-25
- First posted
- 2018-07-27
- Last updated
- 2021-12-03
Locations
39 sites across 9 countries: United States, Austria, Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03603288. Inclusion in this directory is not an endorsement.