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Antioxidant

idebenone 150 mg film-coated tablets for Duchenne Muscular Dystrophy (SIDEROS-E Trial)

Phase 3
Waitlist Available
Research Sponsored by Santhera Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until visit 4 (week 78)
Awards & highlights
No Placebo-Only Group
Pivotal 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.

Eligible Conditions
  • Duchenne Muscular Dystrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until visit 4 (week 78)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until visit 4 (week 78) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of adverse events, as per ICH Topic E2A
Number of patients with abnormal ECG.
Number of patients with abnormal safety laboratory parameters.
+2 more
Secondary study objectives
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) as percent of predicted (FEV1%p)
Change from Baseline in Forced Vital Capacity (FVC) as percent of predicted (FVC%p).
Change from Baseline in Peak Expiratory Flow (PEF) as percent of predicted (PEF%p)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: idebenone 150 mg film-coated tabletsExperimental Treatment1 Intervention
900 mg idebenone/day (2 tablets to be taken 3 times a day with meal)

Find a Location

Who is running the clinical trial?

Santhera PharmaceuticalsLead Sponsor
30 Previous Clinical Trials
2,575 Total Patients Enrolled
~22 spots leftby Dec 2025
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