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Completed Phase 3 Interventional Results available

Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)

ClinicalTrials.gov ID: NCT01027884

Public ClinicalTrials.gov record NCT01027884. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed.

Study identification

NCT ID
NCT01027884
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Santhera Pharmaceuticals
Industry
Enrollment
65 participants

Conditions and interventions

Eligibility (public fields only)

Age range
10 Years to 18 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2009
Primary completion
Dec 31, 2013
Completion
Mar 31, 2014
Last update posted
Oct 18, 2015

2009 – 2014

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
University of California Davis Medical Center Sacramento California 95817
Children's Hospital Colorado Aurora Colorado 80045
University of Florida Gainesville Florida 32610
Carolinas Medical Center, Neurosciences and Spine Institute Charlotte North Carolina 28207
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104-1771
Monroe Carell, Jr. Children's Hospital at Vanderbilt Nashville Tennessee 37232
University of Texas Southwestern Medical Center Dallas Texas 75390-9105
Methodist Neurological Institute Houston Texas 77030
Seattle Children's Hospital Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01027884, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 18, 2015 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01027884 live on ClinicalTrials.gov.

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