Phase 4 N=22 Responses to Influenza Vaccine in Patients With Mitochondrial Disorders (MELAS)
MELAS Syndrome
Primary: Clinical Safety of TIV Vaccine — 4; 0; 0; 0 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=32 A Dose-escalating Clinical Trial With KH176
MELAS · LHON · Leigh Syndrome
Primary: SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF) — 386.2; 395.0; 385.8; 399.3 msec
N/A N=110 Mitochondrial Stress, Brain Imaging, and Epigenetics
Mitochondrial Diseases
Primary: Average TSST-induced Elevation in Cortisol — 37.44; 33.86; 42.83; 45.42 ng*min/mL
Phase 2 N=30 Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study
Primary Mitochondrial Disease
Primary: Distance Walked on the 6-minute Walk Test (6MWT) by Visit — 394.1; 378.2 meters
Phase 2 N=20 EPI-743 for Metabolism or Mitochondrial Disorders
Mitochondrial Disease · Neurology · Myopathy
Primary: Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) Part I-III, Baseline — 23.9; 20.4 Units on a scale
Phase 2 N=36 Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy
Mitochondrial Myopathy
Primary: Change in Distance Walked (Meters) on the 6-minute Walk Test (6MWT) — 13.5; 36.5; 64.5; 20.4 meters
Phase 2 N=27 Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes
MELAS Syndrome
Primary: Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy) — -0.09; 0.16; -0.49 IU
Phase 2 N=39 Melatonin and the Metabolic Syndrome
Metabolic Syndrome
Primary: Metabolic Syndrome Components — -2.7; 4.7 mmHg — p=0.013
Phase 2 N=53 RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
MItochondrial Myopathies
Primary: Change of Peak Workload (in Watts/kg) During Exercise Testing — 0.0090; 0.020; -0.0300; 0.1050 Watts/kg — p=0.7321
N/A N=27 Composition & Function of Sarcoplasmic Reticulum in Persons With the Metabolic Syndrome
Metabolic Syndrome
Primary: Sarcoplasmic Reticulum Composition — 2.0; 2.2 PC:PE ratio
N/A N=98 Dietary Ketosis: Fatty Acids Activate AMPK Energy Circuits Modulating Global Methylation
Mild Cognitive Impairment · Metabolic Syndrome
Primary: MoCA (Montreal Cognitive Assessment) — 28.38; 20.22 score on a scale — p=<0.0001
N/A N=55 Evaluating Mitochondrial Dysfunction in Patients With Neurofibromatosis Type 1
Neurofibromatosis 1
Primary: Mitochondrial Respiration Efficiency (as Measured by OCR). — 67.7167; 53.7000; 73.3358; 68.5789 picomole/minute — p=<0.01
Phase 2 N=40 The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder
Bipolar Depression
Primary: The 25-Item Hamilton Depression Rating Scale. — 23.3; 22.1; 17.5; 18.5 units on a scale
Phase 2 N=36 Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease
Inherited Mitochondrial Disease, Including Leigh Syndrome
Primary: Change From Baseline in Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) Sections I-IV — -0.3; 0.1; -0.6; 0.0 units on a scale — p=0.1875
Phase 3 N=24 Phase III Trial of Coenzyme Q10 in Mitochondrial Disease
Mitochondrial Diseases
Primary: McMaster Gross Motor Function (GMFM 88) — -0.002; -0.12 units on a scale — p=0.95
Phase 1 N=6 Safety, Blood Levels and Effects of AUT00201 in Patients With MEAK
Myoclonus Epilepsies, Progressive
Primary: Number of Participants With Treatment-Related Adverse Events After Single Dose Treatment of AUT00201 Compared to Placebo — 5; 5 Participants
N/A N=12 Metabolic Syndrome and Fall Risk
Metabolic Syndrome · Autonomic Neuropathy
Primary: Four Square Step Test (FSST) — 11.04; 14.29 seconds
Phase 2 N=61 Heart Rate Variability in Response to Metformin Challenge
Fibromyalgia · Mitochondrial Diseases · Movement Disorders
Primary: Heart Rate Variability (Time Domain) — 0.92; 0.83 msec/msec — p=0.77
Phase 2 N=212 An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar (REN001) in Primary Mitochondrial Myopathy Patients
Primary Mitochondrial Myopathy
Primary: Change in Distance Walked During a 12 Minute Walk Test — 26.75; 30.89 meters
Phase 2 N=11 Mitochondria and Chronic Kidney Disease
Hemodialysis-Induced Symptom · Mitochondrial Diseases
Primary: Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) — 60.59; 62.66 seconds
N/A N=14 Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
Peripheral Arterial Disease · Peripheral Artery Disease
Primary: Endothelial Function — 6.13; 3.78 % dilation
Phase 2 N=41 A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly
Skeletal Muscle Mitochondrial Dysfunction in the Elderly
Primary: Change From Baseline in ATPmax (Maximal ATP Synthetic Rate) — 0.17; 0.12; 0.09; 0.06 mM/sec
N/A N=6 Testing Glial Pathways to HAAF in Human Subjects Using Carbon 13 Magnetic Resonance Spectroscopy
Diabetes Complications · Hypoglycemia
Primary: Percent Enrichment of Bicarbonate as Measured by Magnetic Resonance Spectroscopy (MRS) — 61.9 % enrichment — p=0.0053
N/A N=30 Alleviation Of Metabolic Endotoxemia In Adults With Metabolic Syndrome With Milk Fat Globule Membrane
Metabolic Syndrome · Metabolic Endotoxemia
Primary: Serum Endotoxin — 32.5; 30.6 EU/ml
Phase 2 N=15 A Pilot Trial of Triheptanoin for People With Amyotrophic Lateral Sclerosis (PALS)
ALS
Primary: ALS Functional Rating Scale-revised Version (ALSFRS-R) Slope — -0.39; -0.57 points per month — p=0.32
Phase 2 N=38 HSCT for High Risk Inherited Inborn Errors
Adrenoleukodystrophy · Metachromatic Leukodystrophy · Globoid Cell Leukodystrophy
Primary: Number of Patients With Donor Cell Engraftment — 26 Participants
Phase 2 N=93 S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
Multiple Myeloma · Plasma Cell Myeloma
Primary: Overall Survival — 68 Months
Phase 3 N=12 A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome
Barth Syndrome
Primary: Part 1: Distance Walked During the 6-Minute Walk Test (6MWT) by Visit — 400.1; 412.6; 443.1; 443.9 meters
Phase 2 N=1 Nicotinamide Riboside on Mitochondrial Function in Li-Fraumeni Syndrome
Cancer · Skin Fibroblasts · Muscle Weakness
Primary: Change in PCr Recovery Tc Measurement From Baseline to 12 Week NR Supplementation Using the 31P-MRS Skeletal Muscle Submaximal Exercise. — 60; 73 Seconds
Phase 2 N=35 Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)
Metabolic Syndrome X · Overweight · Hypertension
Primary: Insulin Sensitivity — .56; 0.55; 0.66; 0.70 % suppression inf rate 56 pmol/m2/min