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Sponsored by: |
Santhera Pharmaceuticals |
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Information provided by: | Santhera Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00654784 |
Idebenone is a synthetic analogue of coenzyme Q10 and is a powerful antioxidant and essential constituent of the process of energy production on the cellular level. It can protect mitochondria (the powerplants of the body's cells) from oxidative damage and boost their impaired function. It is thought that this mechanism will slow decline in heart function that is part of the disease process of Duchenne Muscular Dystrophy (DMD). It is possible that patients may benefit in terms of muscle strength and respiratory function. This pilot trial is designed to investigate this.
Condition | Intervention | Phase |
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Duchenne Muscular Dystrophy (DMD) |
Drug: idebenone Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIa Double Blind, Randomised, Placebo Controlled, Single Centre Study at the University of Leuven to Assess the Efficacy and Tolerability of Idebenone in 8 - 16 Year Old Males With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy |
Enrollment: | 21 |
Study Start Date: | October 2005 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: idebenone
idebenone 450 mg/day (150 mg three times a day)
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2: Placebo Comparator | Drug: placebo |
Ages Eligible for Study: | 8 Years to 16 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SNT-II-001 |
Study First Received: | April 3, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00654784 History of Changes |
Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Duchenne Muscular Dystrophy DMD Duchenne |
Becker's Muscular Dystrophy Antioxidants Idebenone Muscular Dystrophy, Duchenne and Becker Type Muscular Dystrophies Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases |
Neuromuscular Diseases Genetic Diseases, Inborn Muscular Dystrophy, Duchenne Duchenne Muscular Dystrophy Genetic Diseases, X-Linked Atrophy Muscular Dystrophy |
Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Idebenone Protective Agents Pharmacologic Actions Muscular Dystrophies |
Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Neuromuscular Diseases Genetic Diseases, Inborn Muscular Dystrophy, Duchenne Genetic Diseases, X-Linked |