The main goal of the study is to investigate how well the new drug SUL-238 works in Parkinson's Disease (PD). This is done by means of an MRS scan. An MRS scan is similar to a regular MRI scan. It will also learn about the safety of new drug SUL-238. The main questions it aims to answer are:
* Does new drug SUL-238 improve the mitochondrial function in patients with Parkinson's Disease (PD)? * What medical problems do participants have when taking new drug SUL-238?
Researchers will compare new drug SUL-238 to a placebo (a look-alike substance that contains no drug) to see if SUL-238 works to improve mitochondrial function in patients with PD.
Participants will:
* Take new drug SUL-238 or a placebo every day for 28 days * Visit the clinic once every 2 weeks for checkups and tests during the treatment period and finally 28 days after the last dose of SUL-238 * Keep a diary of their symptoms and the number of times they use oral new drug SUL-238
muscular rigidity
rest tremor (4-6 Hz)
postural instability unrelated to primary visual, cerebellar, vestibular or proprioceptive dysfunction.
The duration of PD since diagnosis is ≤ 1 year.
Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
Any history of intellectual disability or psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, except a history of mild depression/anxiety that has been resolved for at least the past 3 months.
A positive answer to questions 3 through 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
A positive Hepatitis B surface antigen, Hepatitis C antibody, or Human Immunodeficiency Virus (HIV) antibody test at screening.
Parallel
SUL-238 (1500 mg t.i.d.) film-coated tablets
DrugOral treatment with high dose SUL-238 for 28 days
SUL-238 (500 mg t.i.d.) film-coated tablets
DrugOral treatment with low dose SUL-238 for 28 days
Placebo
DrugOral treatment with placebo for 28 days
Assessment of the effect of SUL-238 on mitochondria-related brain metabolites in Parkinson's Disease (PD) Patients
Mean change from baseline to Week 4 in each active dose group as compared to placebo in the concentration of mitochondria-related brain metabolites (ATP, phosphocreatine and inorganic phosphate), as measured by ³¹P-Magnetic Resonance Spectroscopic (MRS) imaging, in the following regions of interest: 1. Putamen, 2. Substantia Nigra, 3. Motor Cortex
Assessment of the effect of SUL-238 treatment on systemic biomarkers of mitochondrial function and associated pathways in Parkinson's Disease (PD) patients by predefined mitochondria related plasma targeted metabolomics
Mean change from baseline to Week 4 in each active dose group as compared to placebo in the circulating levels of established indicators of mitochondrial dysfunction such as lactate, pyruvate and lysophosphatidylcholine
Assessment of the effect of SUL-238 treatment on systemic biomarkers of mitochondrial function and associated pathways in Parkinson's Disease (PD) patients by predefined mitochondria related plasma targeted proteomics
Mean change from baseline to Week 4 in each active dose group as compared to placebo in the circulating levels of established indicators of mitochondrial dysfunction such as cell-free Cytochrome c, creatinine and succinate dehydrogenase (SDH)
Assessment of safety and tolerability of SUL-238 in Parkinson's Disease (PD) Patients
Safety and tolerability of SUL-238 will be assessed by the number of participants; 1. with adverse events, 2. with abnormal laboratory test results, 3. abnormal vital signs, 4. abnormal electrocardiogram, 5. abnormal physical and neurological examination
Assessment of the effect of SUL-238 compared to placebo in improving motor symptoms in Parkinson's Disease (PD) Patients
Mean change from baseline to Week 4 in The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (score range: 0-132, higher scores mean a worse outcome) compared with placebo
Assessment of the effect of SUL-238 compared to placebo on global cognitive function in Parkinson's Disease (PD) Patients
Mean change from baseline to Week 4 in the Montreal Cognitive Assessment (MoCA) score (score range: 0-30, higher scores mean a better outcome), compared with placebo
Characterization of the plasma pharmacokinetic profile of SUL-238
Quantify SUL-238 (as SUL-138) concentrations in plasma at specified time points: 1. Day 1: Pre-dose, 1-hour postdose 2. Day 14: Pre-dose 3. Day 28: Pre-dose, 1-hour postdose, 4-hours post-dose
Characterization of the pharmacokinetic profile of SUL-238 in cerebrospinal fluid (CSF)
Quantify SUL-238 (as SUL-138) concentration in CSF at a single time point: 4-hours post-dose on Day 28 (in consenting patients).
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GEN İlaç ve Sağlık Ürünleri A.Ş.
Lead sponsor
Sulfateq B.V.
Collaborator
