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Mitochondrial Diseases clinical trials

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NCT ID: NCT02154711 Completed - Clinical trials for Mitochondrial Disease

Magnetic Resonance Imaging (MRI) Muscle Phenotyping in Mitochondrial Disease

Start date: May 2014
Phase:
Study type: Observational

The purpose of the study is to use a new research imaging technique, a kind of magnetic resonance imaging (MRI), to measure important metabolic features of muscle, including mitochondrial function, in people with mitochondrial disease and in healthy individuals. (Mitochondria are tiny organelles that generate energy for the body.) It is hoped that this new strategy will help physicians to understand better the health problems of people with mitochondrial disease. Eventually, this could lead to better diagnostic and treatment approaches.

NCT ID: NCT02023866 Completed - Clinical trials for Inherited Mitochondrial Disease, Including Leigh Syndrome

Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease

MITO-001
Start date: May 2014
Phase: Phase 2
Study type: Interventional

To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) administered up to 1.3 g/m²/day in two divided doses, every 12 hours, for up to 6 months in patients with inherited mitochondrial disease.

NCT ID: NCT01831934 Completed - MELAS Syndrome Clinical Trials

Responses to Influenza Vaccine in Patients With Mitochondrial Disorders (MELAS)

Start date: September 2010
Phase: Phase 4
Study type: Interventional

This pilot clinical study, funded by the National Institutes of Health, will evaluate the safety and metabolic responses to a licensed inactivated seasonal influenza vaccine (TIV). This single arm study will consist of two cohorts: MELAS syndrome volunteers (a specific identified disorder of mitochondrial dysfunction: mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes) between 13-60 years for OR adult control volunteers between 18-65 years of age. Both cohorts will receive the same treatment: a single vaccination with an FDA-licensed intramuscular seasonal trivalent inactivated influenza vaccine (TIV).

NCT ID: NCT01776918 Completed - Clinical trials for Mitochondrial Disease

Energy Requirements in Mitochondrial Disease

Start date: February 2012
Phase: N/A
Study type: Observational

Metabolic diseases and mitochondrial disorders are caused by genetic mutation which lead to disruptions in energy producing pathways in our body. Enough energy or calories must be given in the diet to ensure normal growth and development. Currently, energy needs for patients with metabolic and mitochondrial diseases are not measured, but is estimated using a mathematical equation based on healthy children. This may lead to under feeding or overfeeding of calories, and has negative nutritional implications. The clinical standard for measuring energy needs is the use of indirect calorimeter.The indirect calorimeter takes individualized measurements for each patient and therefore will enable dietitians and clinicians to provide sufficient calories in the diet to better manage the disease and promote normal growth and development. We believe daily energy requirements will vary within metabolic diseases (Phenylketonuria) and mitochondrial disorders (mitochondrial fatty acid oxidation defect, POLG1 mutation etc.). The objective of this preliminary study is to measure resting energy expenditure in children living with metabolic and mitochondrial conditions and data obtained will be used to generate future hypothesis and will form a basis for future studies.

NCT ID: NCT01642056 Completed - Myopathy Clinical Trials

EPI-743 for Metabolism or Mitochondrial Disorders

Start date: September 1, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Mitochondria are the parts of cells that help produce energy. Metabolism is the process by which the body uses energy to help cells grow and reproduce. Metabolic and mitochondrial disorders affect the body s ability to produce and store energy. These disorders can cause a wide variety of problems, but most often they affect the muscles and the brain, where energy requirements are high. Treatment is difficult because the exact source of the problem is hard to detect. - EPI-743 is a new drug that is based on vitamin E. Tests have shown that it can help improve the function of cells with mitochondrial problems. It may be able to treat people with genetic disorders that affect metabolism and mitochondria. Objectives: - To see if EPI-743 can improve energy production and use in people with mitochondrial or metabolic disorders. Eligibility: - Children between 2 and 11 years of age who have metabolic or mitochondrial problems. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - The study will last about 13 months. Participants will have seven 3- to 5-day inpatient study visits about 3 months apart. - Participants will take either EPI-743 or a placebo for the first 6 months of the study. After 6 months, there will be a 1-month rest period. Then, those who received EPI-743 in the first 6 months will take the placebo for the next 6 months. Those who had the placebo will take EPI-743. - During each inpatient study visit, participants will have a physical exam. A 24-hour urine collection will be obtained. Blood samples will also be taken. Imaging studies and other tests may be performed as directed by the study researchers.

NCT ID: NCT01301235 Completed - Clinical trials for Mitochondrial Disease

Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy

Start date: February 2011
Phase: N/A
Study type: Observational

This is a developmental protocol to determine the MRI based 31P-MRS changes seen in subjects with mitochondrial myopathy using our dynamic exercise protocol and to identify the ideal variable(s) to represent mitochondrial function.

NCT ID: NCT01264471 Completed - Gulf War Syndrome Clinical Trials

Mechanisms of Mitochondrial Defects in Gulf War Syndrome

Start date: May 2009
Phase: N/A
Study type: Observational

The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the "power plants" of the body. Mitochondria take the food you eat and break the food down into a form of energy that the body can use. The investigators propose that Gulf War Syndrome is determined by a complex interaction of factors that interfere with mitochondrial function. This study will be the first investigation of mitochondrial function in Gulf War Syndrome. The investigators objective is to establish the cause for symptoms in affected veterans, develop testing that can more easily identify Gulf War Syndrome, and ultimately develop treatment protocols for Gulf War Syndrome.

NCT ID: NCT01252979 Completed - Clinical trials for Mitochondrial Diseases

Ketones & Mitochondrial Heteroplasmy

Start date: December 2010
Phase: Phase 0
Study type: Interventional

The current study is a prospective evaluation of the ability of ketosis to shift mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known mutation in their mtDNA at position 3243 (A>G). Subjects will be given supplemental medium chain triglycerides (MCTs) for a period of 6 months. mtDNA heteroplasmy will be measured 3 months prior to treatment, at treatment initiation, and 6 months after initiation. The primary objective of the current study is to determine if there is a shift in heteroplasmy in patients harboring the 3243 A>G mtDNA mutation to a more favorable (higher wild-type) profile while in a state of ketosis.

NCT ID: NCT01137240 Completed - Clinical trials for Gastrointestinal Dysfunction

Gastrointestinal Dysfunction in Children Affected With Mitochondrial Disorders

Start date: June 2010
Phase: N/A
Study type: Observational

Hypothesis: Many patients with underlying mitochondrial disorders have feeding problems because of poor gastrointestinal motility; feeding problems lead to growth impairment and many affected children are malnourished.

NCT ID: NCT00983788 Completed - Clinical trials for Very Long Chain Acyl Coa Dehydrogenase Deficiency

Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects

Bezafibrate
Start date: October 2009
Phase: Phase 2
Study type: Interventional

The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized, double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers: Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after infusion of stable isotopes (palmitate and glucose tracers).