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A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids

NCT02814019 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2021-12-03

No results posted yet for this study

Summary

The purpose of the study is to assess the efficacy of idebenone in delaying the loss of respiratory function in patients with DMD receiving concomitant glucocorticoid steroids

Conditions

  • Duchenne Muscular Dystrophy (DMD)

Interventions

DRUG

Idebenone 150 mg film-coated tablets

DRUG

placebo

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02814019 on ClinicalTrials.gov