Clinical trials: Lactic Acidosis
MELAS Syndrome
Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes
The purpose of this study is to compare the efficacy of two (2) different doses of idebenone with that of a placebo over a one month period on cerebral lactate concentration as measured by magnetic resonance spectroscopy.
- Trial name
- MELAS (NCT00887562)
- Testing
- Idebenone
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Michio Hirano
Lactic Acidosis
Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia
OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients with congenital lactic acidemia. II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute episodes of…
- Trial name
- NCT00004493
- Testing
- sodium dichloroacetate
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- University of California, San Diego
Mitochondrial Diseases
A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease
A long-term extension study to assess the safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) in children with inherited mitochondrial diseases who previously enrolled into study…
- Trial name
- NCT02473445
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Amgen
Acute Stroke, Hyperglycemia
SELESTIAL: Trial of Insulin to Control Blood Sugar After Acute Stroke Using Magnetic Resonance Imaging (MRI) End-Points
High blood sugar (hyperglycaemia) affects 40% of acute stroke patients and has a major adverse effect on survival and recovery. Increased production of lactic acid in brain tissue that has a poor blood supply is postulated to be…
- Trial name
- NCT00124826
- Testing
- Insulin
- Where
- United Kingdom
- Volunteers
- 45 people
- Sponsor
- University of Glasgow
Acidosis, Lactic
Whole Body Periodic Acceleration on Blood Lactate and Recovery
Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6.
- Trial name
- NCT02482597
- Testing
- Whole Body Periodic Acceleration
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- New York Institute of Technology
Acidosis, Lactic, Chronic Disease
Prevention of Dichloroacetate Toxicity
This is a study to determine the safety of dichloroacetate (DCA) with a low-tyrosine diet given with or without nitisinone (NTBC) in children with chronic lactic acidosis (CLA).
- Trial name
- NCT00031161
- Testing
- Nitisinone (NTBC), Dichloroacetate, Low-tyrosin diet
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
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
Shock, Hemorrhagic, Shock, Traumatic
Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients
MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid.
- Conditions
- Shock, Hemorrhagic, Shock, Traumatic, Acidosis, Lactic
- Trial name
- NCT01262196
- Testing
- MP4OX, Saline
- Where
- 40 sites in Australia, Austria and 12 more
- Volunteers
- 348 people
- Sponsor
- Sangart
Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
The KHENEREXT Study
This is an open-label, multi-centre study in subjects with a genetically confirmed mitochondrial deoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation who completed study KH176-202.
- Conditions
- Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation, Maternally Inherited Diabetes and Deafness (MIDD), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke Like Episodes (MELAS)
- Trial name
- NCT04604548
- Testing
- Oral administration of 100 mg KH176 twice daily
- Where
- 4 sites in Denmark, Germany and 2 more
- Volunteers
- 11 people
- Sponsor
- Khondrion BV
Diabetes Mellitus, Coronary Artery Disease
Metformin in Diabetic Patients Undergoing Coronary Angiography
The present study aims to evaluate the strict application of the 2018 European Society of Cardiology guidelines on myocardial revascularization, that recommends to check renal function if patients have taken metformin immediately…
- Conditions
- Diabetes Mellitus, Coronary Artery Disease, Lactic Acidosis With Diabetes Mellitus, Contrast-induced Nephropathy
- Trial name
- NO-STOP (NCT04766008)
- Testing
- Metformin
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Humanitas Hospital, Italy
Asthma
The Various Effects of Gaseous Albuterol on Serum Lactate
Empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy.
- Trial name
- NCT02073747
- Testing
- Normal Saline, Albuterol
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University Medical Center of Southern Nevada
HIV, Hepatitis B
EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV
The EuroSIDA study is a prospective observational cohort study of 23,000+ patients followed in 100+ clinics in 35 European countries, Israel and Argentina.
- Conditions
- HIV, Hepatitis B, Hepatitis C, AIDS
- Trial name
- EuroSIDA (NCT02699736)
- Where
- 110 sites in Argentina, Austria and 34 more
- Volunteers
- 23,000 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Acidosis, Lactic
D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)
The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed.
- Trial name
- NCT00143702
- Testing
- d4T, Abacavir, Riboflavin and Thiamine (Supplementation)
- Where
- 2 sites in Canada
- Volunteers
- 80 people
- Sponsor
- University of British Columbia
Alcohol Withdrawal, Lactic Acidosis
Alcohol: Thiamine and or Magnesium 1
Patients who suffer Alcohol Use Disorder (AUD) have a 30-80% incidence of thiamine deficiency causing Wernicke's Encephalopathy (WE).
- Conditions
- Alcohol Withdrawal, Lactic Acidosis, Vitamin B1 Deficiency, Magnesium Deficiency
- Trial name
- AToM1 (NCT03466528)
- Testing
- Magnesium Sulfate, Pabrinex
- Where
- United Kingdom
- Volunteers
- 127 people
- Sponsor
- Glasgow Royal Infirmary
MELAS Syndrome, Lebers Hereditory Optic Neuropathy With Extra Ocular Symptoms (LHON-Plus)
A Basket Clinical Study to Assess Glycerol Tributyrate in Patients With Mitochondrial Encephalopathy, Lactic Acidosis, Stroke-like Episodes (MELAS) or Leber's Hereditary Optic Neuropathy-Plus (LHON-Plus)
This is a parallel arm non-randomized dose-escalation, open-label basket exploratory phase 1 clinical trial where Mitochondrial encephalopathy, lactic acidosis, stroke-like episodes (MELAS) and Leber's hereditary optic…
- Trial name
- NCT06792500
- Testing
- Glycerol Tributyrate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- George Washington University
Lactic Acidosis
Lactic Acidosis During Entecavir(ETV)Treatment
The purpose of this study is to investigate whether entecavir treatment increases the incidence of lactic acidosis compared to another nucleoside/nucleotide reverse transcriptase inhibitors (NRTI), lamivudine, and/or no NRTI…
- Trial name
- ETV (NCT01354652)
- Testing
- entecavir, lamivudine
- Volunteers
- 5 people
- Sponsor
- Asan Medical Center
Anemia
RBC Transfusion in Severe Anemia With Lactic Acidosis
The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.
- Trial name
- TOTAL (NCT01586923)
- Testing
- RBC transfusion
- Where
- Uganda
- Volunteers
- 290 people
- Sponsor
- Massachusetts General Hospital
Type 2 Diabetes, Chronic Kidney Disease
Metformin Use in Chronic Kidney Disease: The CKD-Met Study
Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit. Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD)…
- Trial name
- CKD-Met (NCT02844153)
- Testing
- modalities of metformin prescription
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Hospices Civils de Lyon
Congenital Lactic Acidosis
Pharmacotoxicology of Trichloroethylene Metabolites
To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism. This aim test the postulates that MAAI haplotype determines, and thus can predict,1) dose-dependent DCA kinetics and biotransformation.
- Trial name
- NCT00874276
- Testing
- Dichloroacetate (DCA), Genetic Marker on Chromosome 14q24.3
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Florida
MELAS Syndrome
Clinical Long Term Evaluation of Glutamine Supplement in MELAS Syndrome
The purpose of this study is to assesses the clinical efficacy of oral supplementation with glutamine over 3 years.
- Trial name
- NCT05255328
- Testing
- Glutamine oral supplement
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- Hospital Universitario 12 de Octubre