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New treatment option for Parkinson's Disease (PD)
Official title 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
ClinicalTrials.gov ID: NCT07322887
What this study is testing
What is SUL-238 (1500 mg t.i.d.) film-coated tablets?
SUL-238 (1500 mg t.i.d.) film-coated tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for parkinson's disease (pd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Untreated Parkinson's Disease (PD) patients diagnosed in accordance with the UK PDS Brain Bank Criteria for the diagnosis of PD. Patients must have...
- 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.
You likely can't join if
- Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or...
- Any history of intellectual disability or psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical...
- 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...
- Received or used an investigational product (including placebo) or device within the following time period prior to day -1 in the current study: 90...
See the full eligibility 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.
- Able to understand the nature of the study and provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures.
- Able to complete all study related testing and evaluations.
- Patients must be, in the opinion of the Investigator, able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant.
- Men and women of child-bearing potential with partners of child-bearing potential must agree to use highly effective contraception. For male patients, contraception should continue for 3 months after the last dose of...
- Women of non-childbearing potential must be post-menopausal (the last menstrual period was at least 12 months ago, and follicle-stimulating hormone [FSH] at screening confirms post-menopausal status), or have no uterus...
- 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...
- 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...
- 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...
- Use of drugs which are strong inhibitors of CYP3A4 or CYP3A4 substrates with narrow therapeutic index within 30 days prior to day -1.
- History of clinically significant sensitivity to any of the study medications, or components thereof or a history of drug or other allergies that, in the opinion of the Investigator or Medical Monitor, contraindicates...
- Women with a positive pregnancy test, are lactating, or are planning to become pregnant during the study or within 6 months of the end of this study.
- A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, metabolism, or excretion. Patients with a history of cholecystectomy should be excluded.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, or neurologic (other than PD) abnormality.
- At screening, any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgement of the Investigator or Medical Monitor, may...
- A clinically significant vital signs abnormality at screening or day -1. This includes, but is not limited to, the following, in the sitting position (3 measurements, each 5 minutes apart):
- systolic blood pressure (SBP) \ 140 mmHg,
- diastolic blood pressure (DBP) \ 95 mmHg, or
- heart rate \ 100 beats per minute.
- In the opinion of the Investigator or Medical Monitor, the patient is unlikely to comply with the protocol or is unsuitable for any reason, e.g., known issues with ability to swallow tablets.
- Women of child-bearing potential (WOCBP), or men, who are unwilling or unable to use accepted methods of birth control for up to 6 months following study participation. 16\. Contraindications for undergoing an MRI.
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.