A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patien… (NCT07322887) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patients With Early, Untreated Parkinson's Disease
Netherlands45 participantsStarted 2026-03-02
Plain-language summary
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
Who can participate
Age range40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Untreated Parkinson's Disease (PD) patients diagnosed in accordance with the UK PDS Brain Bank Criteria for the diagnosis of PD. Patients must have bradykinesia and at least one of the following:
✓. 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.
✓. Patients with Modified Hoehn and Yahr stage ≤ 1.0.
✓. Patients with Montreal Cognitive Assessment (MOCA) score of ≥22.
✓. Men and women aged ≥40 years at screening.
Exclusion criteria
✕. Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
What they're measuring
1
Assessment of the effect of SUL-238 on mitochondria-related brain metabolites in Parkinson's Disease (PD) Patients
Timeframe: At baseline and end of treatment at 4 weeks
. 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.
✕. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN) at screening or between screening and first dose administration.
✕. Received or used an investigational product (including placebo) or device within the following time period prior to day -1 in the current study: 90 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
✕. Use of non-prescription drugs, vitamins, herbal, and dietary supplements which has potential to influence the mitochondrial function (such as coenzyme Q10, carnitine, creatine, lipoic acid and vitamin E) within 30 days prior to day -1.
✕. Use of drugs which are strong inhibitors of CYP3A4 or CYP3A4 substrates with narrow therapeutic index within 30 days prior to day -1.