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Duchenne Muscular Dystrophy clinical trials

View clinical trials related to Duchenne Muscular Dystrophy.

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NCT ID: NCT02421523 Completed - Clinical trials for Duchenne Muscular Dystrophy

Strength Training in Duchenne Muscular Dystrophy

Start date: May 30, 2015
Phase: N/A
Study type: Interventional

Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle breakdown, weakness, and eventual death. Over the last 40 years parents have received little guidance on the potential of exercise as a therapeutic strategy to maintain muscle function. It is well known that high intensity exercise and eccentric contractions can result in muscle damage in dystrophic muscle, yet the absence of muscle loading will conversely result in muscle wasting. Recent research in rodent models and milder forms of muscular dystrophy supports earlier studies that resistance exercise may have beneficial effects for maintenance of muscle mass in dystrophic muscle. However, careful and systematic investigation into the safety and feasibility of resistance exercise is needed to consider its implementation in boys with DMD. The goal of this project is to assess the safety and feasibility of a home based mild to moderate-intensity strengthening exercise program in boys with Duchenne muscular dystrophy (DMD). Evidence from milder forms of muscular dystrophy and mouse models of DMD suggests that strengthening exercise may be beneficial for these children, but this area has not been adequately explored using human subjects. The results of this study should provide information to assist in the development of scientifically based recommendations concerning optimal exercise parameters for patients with DMD.

NCT ID: NCT02418338 Completed - Clinical trials for Duchenne Muscular Dystrophy

2D Strain Evaluation: Children With Duchenne Muscular Dystrophy Versus Healthy Children

Start date: January 2014
Phase: N/A
Study type: Interventional

Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.

NCT ID: NCT02376816 Completed - Clinical trials for Duchenne Muscular Dystrophy

Clinical Intramuscular Gene Transfer Trial of rAAVrh74.MCK.Micro-Dystrophin to Patients With Duchenne Muscular Dystrophy

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The proposed phase I clinical trial is a pilot study to evaluate safety and biological activity of the rAAVrh74.MCK.micro-Dystrophin vector administered by an intramuscular route. This study will evaluated the micro-Dystrophin vector as a potential dystrophin replacement mechanism for Duchenne Muscular Dystrophy. Two cohorts will undergo gene transfer in a standard three-six dose escalation scheme to establish maximum tolerated dose (MTD) using toxicity. A minimum of three subjects will be enrolled into each cohort. The first cohort will receive a total dose of 3E11 vg. The second cohort will receive 1E12 vg total dose.

NCT ID: NCT02354781 Completed - Clinical trials for Duchenne Muscular Dystrophy

Clinical Intramuscular Gene Transfer of rAAV1.CMV.huFollistatin344 Trial to Patients With Duchenne Muscular Dystrophy

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The proposed clinical trial is an outgrowth of the safety record and functional improvement seen in the BMD follistatin gene therapy trial. In this study the investigators propose to inject AAV1.CMV.huFS344 at a total dose of 2.4E12 vg/kg to six DMD patients. This dose will be divided between gluteal muscles, quadriceps and tibialis anterior. This is a wider distribution of vector than given to BMD patients, who overall improved the distance walked on the 6MWT without adverse events related to viral transduction into a single muscle.

NCT ID: NCT02354352 Completed - Clinical trials for Duchenne Muscular Dystrophy

Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy

Start date: March 20, 2015
Phase: Phase 3
Study type: Interventional

The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will use a drug diary to record daily compliance of taking the study medication as well as any concerns they may have during the study period. Subjects will undergo cardiac magnetic resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12 months post enrollment. Subjects will also complete a quality of life questionnaire at baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at baseline and 12 months.

NCT ID: NCT02340923 Completed - Clinical trials for Duchenne Muscular Dystrophy

A Device for Rapid, Painless, Bedside Muscle Evaluation of Children

Start date: January 2015
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on healthy children and children with duchenne muscular dystrophy so as to develop a new, convenient tool for the office based assessment of children with a wide variety of neuromuscular conditions.

NCT ID: NCT02310906 Completed - Clinical trials for Duchenne Muscular Dystrophy

Phase I/II Study of SRP-4053 in DMD Patients

Start date: January 13, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.

NCT ID: NCT02295748 Completed - Clinical trials for Duchenne Muscular Dystrophy

An Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability Deflazacort

Start date: December 2014
Phase: Phase 1
Study type: Interventional

This is an open label, long-term extension study in approximately 24 male DMD subjects consisting of children (ages 4-12, inclusive) and adolescents (ages 13-16, inclusive) who participated in the MP-104-CL-005 PK study.

NCT ID: NCT02251600 Completed - Clinical trials for Duchenne Muscular Dystrophy

A Pharmacokinetic Study of Oral Deflazacort in Children and Adolescent Subjects With Duchenne Muscular Dystrophy

Start date: December 2014
Phase: Phase 1
Study type: Interventional

Study to characterize the single-state and steady-state dosing of oral deflazacort in pediatric and adolescents subjects.

NCT ID: NCT02246478 Completed - Clinical trials for Duchenne Muscular Dystrophy

A Study of TAS-205 for Duchenne Muscular Dystrophy

Start date: September 2014
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in patients with Duchenne Muscular Dystrophy.