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

NCT03603288 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2021-12-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

idebenone 150 mg film-coated tablets

900 mg idebenone/day

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-04
Primary Completion
2020-11-25
Completion
2020-11-25
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603288 on ClinicalTrials.gov