Clinical trials: Mitochondrial Disorders
Primary Mitochondrial Disease
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in…
- Trial name
- NCT02976038
- Testing
- elamipretide
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Stealth BioTherapeutics Inc.
Cockayne Syndrome
Metabolic Study of Cockayne Syndrome
Cockayne syndrome (CS) is related to defective DNA transcription and/or repair and belongs to the family of Nucleotide Excision Repair.
- Trial name
- METABO-CS (NCT03044210)
- Testing
- Metabolic evaluation
- Where
- France
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France
Aging, Insulin Sensitivity
Antecedent Metabolic Health and Metformin Aging Study
Aging is the number one risk factor for the majority of chronic diseases. There are no pharmaceutical treatments to slow aging and prolong healthspan.
- Conditions
- Aging, Insulin Sensitivity, Chronic Disease, Mitochondria
- Trial name
- ANTHEM (NCT04264897)
- Testing
- Metformin
- Where
- 2 sites in United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Oklahoma Medical Research Foundation
Friedreich's Ataxia
An Open-label Study of the Effects of Acetyl-L-Carnitine on Cardiovascular Outcomes in Friedreich's Ataxia
The purpose of this study is to learn how treatment with acetyl-L-carnitine (ALCAR) will affect the hearts of patients with Friedreich's Ataxia as well as how it may affect other symptoms of Friedreich's Ataxia such as…
- Trial name
- NCT01921868
- Testing
- Acetyl-L-Carnitine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of South Florida
Inherited Mitochondrial Disease
A Safety Study for Previously Treated Vatiquinone (PTC743) Participants With Inherited Mitochondrial Disease
The primary objective of this study is to assess the safety of vatiquinone in participants with inherited mitochondrial disease who had prior exposure to vatiquinone in a PTC/BioElectron sponsored (previously Edison) clinical…
- Trial name
- NCT05218655
- Testing
- Vatiquinone
- Where
- 26 sites in United States, France and 5 more
- Volunteers
- 101 people
- Sponsor
- PTC Therapeutics
Non Shockable Out of Hospital Cardiac Arrest
Cyclosporine A in Cardiac Arrest
The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and…
- Trial name
- CYRUS (NCT01595958)
- Testing
- Cyclosporine A, cardio-pulmonary resuscitation
- Where
- France
- Volunteers
- 796 people
- Sponsor
- Hospices Civils de Lyon
MELAS Syndrome
Glutamine Supplement in MELAS (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like Episodes) Syndrome
The purpose of this study is to assesses the efficacy of oral supplementation with glutamine over three months on several amino acids and lactate concentration measured in cerebrospinal fluid and cerebral lactate measured by…
- Trial name
- NCT04948138
- Testing
- Glutamine oral supplementation
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- Jesús González de la Aleja Tejera
Mitochondria, Metformin
Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. Metformin Monotherapy
he goal of this clinical trial is to compare the mitochondrial redox effects of imeglimin versus metformin monotherapy in adults with newly diagnosed Type 2 diabetes mellitus who are treatment-naive.
- Trial name
- MIRROR-DM (NCT07436182)
- Testing
- Imeglimin, Metformin 1000 mg Oral Tablet
- Where
- Egypt
- Volunteers
- 176 people
- Sponsor
- Mansoura University
Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion
New Non-invasive Modalities for Assessing Retinal Structure and Function
This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other…
- Conditions
- Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion, Hemianopia, Leber Hereditary Optic Neuropathy
- Trial name
- NCT03475173
- Testing
- LSFG-NAVI
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Randy Kardon
Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
A Phase 2b Study of Zagociguat in Patients With MELAS
PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs.
- Trial name
- PRIZM (NCT06402123)
- Testing
- zagociguat 15mg, zagociguat 30mg
- Where
- 20 sites in United States, Australia and 4 more
- Volunteers
- 43 people
- Sponsor
- Tisento Therapeutics
Type 2 Diabetes, Coronary Heart Disease
Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)
The purpose of this study is to examine the existence of heart abnormalities in patients with diabetes and the effect of pioglitazone in correcting these abnormalities.
- Trial name
- NCT01588470
- Testing
- pioglitazone
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center at San Antonio
Male Infertility, Heart Valve Disease
Warfarin Effects on Male Fertility After Cardiac Surgery
Young male patients undergoing cardiac surgery may require oral anticoagulation with warfarin either lifelong, such as after mechanical valve replacement, or for a limited postoperative period, for example following valve repair…
- Trial name
- NCT07330869
- Testing
- Semen analysis, sperm DNA fragmentation and hormonal evaluation
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Città di Lecce Hospital, GVM Care & Research
Long COVID, Post-COVID-19 Condition
Mitochondrial Function in Peripheral Blood Mononuclear Cells, Muscle, and Skin of Long COVID Patients
Mitochondria are structures inside cells that are responsible for producing energy from nutrients through a series of steps, using oxygen.
- Trial name
- MitoLoCo (NCT07134673)
- Where
- Belgium
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Universitair Ziekenhuis Brussel
Lung Cancer (Diagnosis)
The Effects of Low-Intensity Endurance Exercise on Improving Fatigue, Sleep, Quality of Life, Mitochondrial Function, Cellular Bioelectrical Impedance Phase Angle, and Predictors of Exercise Adherence in Patients With Lung Cancer
To conduct a randomized controlled trial (RCT) targeting lung cancer patients with cancer-related fatigue to achieve the following objectives: Objective 1: To investigate whether a low-intensity endurance exercise intervention…
- Trial name
- NCT07795580
- Testing
- Low-Intensity Continuous Endurance Exercise Training, Low-Intensity Interval Endurance Exercise Training
- Where
- Taiwan
- Volunteers
- 450 people
- Sponsor
- Taipei Medical University
Cytomegalovirus Retinitis, HIV Infections
A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir
To examine the safety and tolerance of the administration of ganciclovir and foscarnet given together or alternately; to determine the interactive pharmacokinetics (blood level) profile of long-term combined and alternating…
- Trial name
- NCT00000970
- Testing
- Foscarnet sodium, Ganciclovir
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection
SNAP: Switching Nucleoside Analogues Protocol - Lipoatrophy and Mitochondrial Function
HIV infected subjects receiving antiretroviral treatment for greater than 6 years with be evaluated for clinical lipoatrophy and mitochondrial function after switching nucleoside analogues from stavudine (d4T) to tenofovir…
- Trial name
- NCT00225082
- Testing
- Nucleoside analogue switch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Northwestern University
OPA1 Gene Mutation, Optic Atrophy, Autosomal Dominant
A Longitudinal Natural History Study of OPA1-Associated Autosomal-Dominant Optic Atrophy
This prospective, monocenter, non-interventional observational study investigates the natural history as well as the clinical and genetic spectrum of OPA1-associated autosomal dominant optic atrophy.
- Trial name
- OPA-LONG (NCT07729982)
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Ludwig-Maximilians - University of Munich
Mitochondrial Diseases
Digital Health Technology for People With Mitochondrial Disease
Abstract: A lack of exercise combined with low levels of activity is prominent in people with Mitochondrial Disease (MD). Unfortunately, access to health professionals such as physiotherapists with experience in MD is difficult…
- Trial name
- NCT06535646
- Testing
- Home exercise program using Physitrack exercise program and a smart watch
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Neuroscience Research Australia
Obesity, Insulin Resistance
Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans
African Americans are at a substantially greater type 2 diabetes risk compared to Caucasians; however, very little data are available on the effects of exercise training on type 2 diabetes risk factors in at risk African…
- Conditions
- Obesity, Insulin Resistance, Sedentary Lifestyle
- Trial name
- HI-PACE (NCT02892331)
- Testing
- Moderate intensity exercise training (MOD-INT), High Intensity exercise training (HI-INT)
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- East Carolina University
PolG, Primary Mitochondrial Myopathy
Prospective Natural History Study of POLG Disease
The PIONEER study is a prospective, natural history study dedicated to characterizing the clinical progression of POLG-related disorders.
- Trial name
- PIONEER (NCT07775872)
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- The POLG Foundation