Clinical trials: Mitochondrial Disorder
Type 2 Diabetes, Oxidative Stress
The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise
Objectives: The research focus of the study is the production of reactive oxygen species (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation and in response to acute exercise.
- Conditions
- Type 2 Diabetes, Oxidative Stress, Mitochondrial Reactive Oxygen Species Production
- Trial name
- DIMITOS (NCT02948673)
- Testing
- Glutathione
- Where
- Denmark
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Parkinson Disease
N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease
N-DOSE is a double-blinded placebo-controlled randomized trial aiming to determine the optimal biological dose (OBD) of nicotinamide riboside (NR), in individuals with Parkinson's disease (PD).
- Trial name
- NCT05589766
- Testing
- Nicotinamide Riboside
- Where
- Norway
- Volunteers
- 81 people
- Sponsor
- Haukeland University Hospital
HIV Infection, Mitochondrial Dysfunction
Switching From Efavirenz to Atazanavir/ Ritonavir in HIV-infected Subjects With Good Virologic Suppression
The purposes of this study are to evaluate if switching an antiretroviral medication from efavirenz (EFV) to atazanavir/ ritonavir (ARV/r) will, in a 96-week period, change: 1.
- Trial name
- NCT01194856
- Testing
- Atazanavir/ritonavir, Efavirenz
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- The Cleveland Clinic
Autism Spectrum Disorder
Effect of a Wide Spectrum Nutritional Supplement on Mitochondrial Function in Children With Autism Spectrum Disorder
The objective of this study is to evaluate the metabolic effects of a comprehensive wide-spectrum supplement for children with ASD to determine whether it physiologically targets mitochondrial pathways known to be abnormal in…
- Trial name
- NCT03835117
- Testing
- Wide-spectrum nutritional supplement
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Rossignol Medical Center
Urea Cycle Disorder, Organic Acidemia
Systemic Biomarkers of Brain Injury From Hyperammonemia
Ammonia is a waste product of protein and amino acid catabolism and is also a potent neurotoxin. High blood ammonia levels on the brain can manifest as cytotoxic brain edema and vascular compromise leading to intellectual and…
- Conditions
- Urea Cycle Disorder, Organic Acidemia, Maple Syrup Urine Disease, Glutaric Acidemia I
- Trial name
- NCT04602325
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's National Research Institute
MELAS
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults diagnosed with MELAS.
- Trial name
- NCT04475549
- Testing
- IW-6463 Tablets
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Tisento Therapeutics
Primary Mitochondrial Diseases
Collection of Blood and Skin Samples From Patients With Primary Mitochondrial Diseases and Healthy Volunteers
Mitochondrial diseases are a genetically diverse group of disorders, some of which are caused by mutations or deletions in the mitochondrial DNA (mtDNA) and which display a wide range of severity and phenotypes.
- Trial name
- NCT06474104
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Minovia Therapeutics Ltd.
Chronic Kidney Disease
Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
The purpose of this study is to examine the effect of mitochondria derived oxidative stress on vascular function in patients with moderate to severe Chronic Kidney Disease.
- Trial name
- NCT02364648
- Testing
- MitoQ
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Delaware
Mitochondrial Diseases, Bone Remodeling Disorder
The Impact of Mitochondrial Dysfunction on Human Bone Cell Metabolism and Remodelling
Cell and mice studies suggest mitochondrial dysfunction may cause altered bone structure. Hypothesis: Decreased mitochondrial energy production affects bone cell development and activity negatively.
- Trial name
- NCT05483738
- Testing
- Clinical assessment, blood samples, bone marrow and bone biopsy
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Aalborg University Hospital
Thymidine Kinase 2 Deficiency
A Study of the Efficacy and Safety of MT1621 in Thymidine Kinase 2 (TK2) Deficiency (Treatment naïve)
This is a Phase 3b, prospective, single-arm, multicenter, open-label treatment study of the efficacy and safety of MT1621 in pediatric and adolescent patients with thymidine kinase 2 deficiency (TK2d).
- Trial name
- NCT04581733
- Testing
- MT1621
- Sponsor
- Zogenix MDS, Inc.
Pediatric Obesity, Insulin Resistance
Intensive Exercise to Improve Mitochondrial Dysfunction in Pediatric Obesity
Obesity and type 2 diabetes are occurring at epidemic rates in the United States and worldwide. The global burden of diabetes is estimated to double over the next 25 years.
- Conditions
- Pediatric Obesity, Insulin Resistance, Mitochondrial Dysfunction
- Trial name
- NCT00962806
- Testing
- Exercise, Lifestyle counseling
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
Mitral Valve Regurgitation, Left Atrium Dilatation and Hypertrophy
Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery
In the absence of treatment, severe mitral valve regurgitation (MR) results in left atrium (LA) dilatation and hypertrophy, followed ultimately by left ventricular dysfunction and heart failure.
- Conditions
- Mitral Valve Regurgitation, Left Atrium Dilatation and Hypertrophy, Mitochondrial Dysfunction in the Heart, Cardiomyocyte Apoptosis
- Trial name
- NCT01046604
- Testing
- Lovaza group
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- East Carolina University
Retinitis Pigmentosa, Leber's Hereditary Optic Neuropathy
Pupil Dynamics and Color Vision for the Detection of Eye Diseases
The development of new oculometry techniques allows fine and dynamic measurements of pupillary diameter and use in routine clinical practice.
- Conditions
- Retinitis Pigmentosa, Leber's Hereditary Optic Neuropathy, Stargardt Disease
- Trial name
- PupDyn (NCT04909398)
- Testing
- Dynamic pupillometry sessions
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Autism Spectrum Disorder, Mitochondrial Pathology
Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
The study involves up to 5 visits for a fasting blood draw, behavioral assessments, and/or questionnaires. Other samples may be collected when appropriate. This study is currently recruiting.
- Conditions
- Autism Spectrum Disorder, Mitochondrial Pathology, Epilepsy, Brain Tumor
- Trial name
- NCT04322734
- Where
- 2 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Southwest Autism Research & Resource Center
Rare Diseases, Mitochondrial Diseases
A Multi-Dimensional Model of cAre and transItion for Patients With cOmplex RAre Diseases
Over the past century, the progress in biomedical sciences gave outstanding contributions to the understanding of human conditions, and even curing some of them.
- Conditions
- Rare Diseases, Mitochondrial Diseases, Muscular Dystrophies, Dysmorphic Disorder, Body
- Trial name
- AD-MAIORA (NCT07558213)
- Testing
- Etiopathogenetic diagnosis, Functional diagnosis
- Where
- Italy
- Volunteers
- 136 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Mitochondrial Diseases
Phase III Trial of Coenzyme Q10 in Mitochondrial Disease
To show that oral CoQ10 is a safe and effective treatment for children with inborn errors of mitochondrial energy metabolism due to defects in specific respiratory chain (RC) complexes or mitochondrial DNA (mtDNA) mutations, and…
- Trial name
- NCT00432744
- Testing
- CoenzymeQ10
- Where
- 3 sites in United States, Canada
- Volunteers
- 24 people
- Sponsor
- University of Florida
Friedreich's Ataxia
Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)
This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreich's ataxia.
- Trial name
- PROTI (NCT01303406)
- Testing
- Idebenone
- Where
- 6 sites in Austria, Germany and 2 more
- Volunteers
- 29 people
- Sponsor
- Santhera Pharmaceuticals
Schizophrenia and Related Disorders, Mitochondrial Alteration
MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction
The goal of this double-blind, placebo-controlled randomized clinical trial is to test the effect of 12 weeks of orally administered MitoQ (mitoquinol mesylate) supplementation on cognition in 50 people with early phase…
- Conditions
- Schizophrenia and Related Disorders, Mitochondrial Alteration, Cognitive Impairment
- Trial name
- NCT06191965
- Testing
- MitoQ
- Where
- 3 sites in United States, Switzerland
- Volunteers
- 100 people
- Sponsor
- Mclean Hospital
MELAS Syndrome, Mitochondrial Respiratory Chain Deficiencies
Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers
The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.
- Trial name
- NCT03056209
- Testing
- KL1333 25 mg, KL1333 50 mg, KL1333 100 mg
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Yungjin Pharm. Co., Ltd.
Friedreich Ataxia, Friedreich's Ataxia
A Study to Evaluate the Efficacy and Safety of Subcutaneous Nomlabofusp in Subjects With Friedreich's Ataxia
To evaluate the efficacy and safety of subcutaneous nomlabofusp in adult and pediatric subjects with Friedreich's ataxia
- Trial name
- FORWARD-FA (NCT07778836)
- Testing
- Nomlabofusp
- Where
- 4 sites in United States
- Volunteers
- 150 people
- Sponsor
- Larimar Therapeutics, Inc.