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NCT01027884 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)
A Phase 3 study of Muscular Dystrophy, Duchenne and Ambulatory Care, sponsored by Santhera Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
- 20
- Study locations
NCT01027884: Completed Phase 3 study of Muscular Dystrophy, Duchenne and Ambulatory Care, sponsored by Santhera Pharmaceuticals.
NCT01027884 is a Phase 3 study of Muscular Dystrophy, Duchenne and Ambulatory Care that has completed, run by Santhera Pharmaceuticals. The registered enrollment target is 65 participants, below the 91-participant average among 4 other Muscular Dystrophy, Duchenne trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01027884, a Phase 3 study of Muscular Dystrophy, Duchenne and Ambulatory Care, has completed, sponsored by Santhera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Change from Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Idebenone
Study Locations (20)
Other
- Dr. Günther Bernert, Prim. Univ. Doz. - Vienna
- University Hospitals Leuven- Children Hospital - Leuven
- Hôpital Roger Salengro, CHRU Lille - Lille
- Prof. Thomas Voit , MD, PhD - Paris
- Universitätsklinikum Essen, Zentrum für Kinderheikunde - Essen
- Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin - Freiburg im Breisgau
- Fondazione IRCCS "Eugenio Medea" - Bosisio Parini, Lecco
- Azienda Ospedaliera Niguarda Ca' Granda Centro Clinico Nemo - Milan
- Azienda Ospedaliera Universitaria della Seconda Università degli Studi di Napoli - Naples
- Hospital Universitario 12 de Octubre - Madrid
Texas
- University of Texas Southwestern Medical Center - Dallas
- Methodist Neurological Institute - Houston
California
- University of California Davis Medical Center - Sacramento
Colorado
- Children's Hospital Colorado - Aurora
Florida
- University of Florida - Gainesville
North Carolina
- Carolinas Medical Center, Neurosciences and Spine Institute - Charlotte
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Tennessee
- Monroe Carell, Jr. Children's Hospital at Vanderbilt - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01027884 record still lists
NCT01027884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 91-participant average among 4 other Muscular Dystrophy, Duchenne trials with a reported enrollment target (29% lower).
The record links to 2 conditions, with Muscular Dystrophy, Duchenne appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01027884 names 20 study sites across 10 states, led by Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT01027884 about?
NCT01027884 is a clinical study titled "Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)". 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.
What is the current status of trial NCT01027884?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2009-07. Estimated completion is 2014-04.
What conditions does trial NCT01027884 study?
This clinical trial studies the following conditions: Muscular Dystrophy, Duchenne, Ambulatory Care.
What interventions are being tested in trial NCT01027884?
The interventions under investigation include: Placebo (DRUG), Idebenone (DRUG).
Who is sponsoring clinical trial NCT01027884?
This trial is sponsored by Santhera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01027884 being conducted?
This trial has 20 study locations across California, Colorado, Florida, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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