Actively Recruiting
A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Effects of SUL-238 on Brain Energy Metabolites Using 31P-MRS in Patients With Early, Untreated Parkinson's Disease
Led by GEN İlaç ve Sağlık Ürünleri A.Ş. · Updated on 2026-03-31
45
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
G
GEN İlaç ve Sağlık Ürünleri A.Ş.
Lead Sponsor
S
Sulfateq B.V.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of a new drug called SUL-238 on patients with early, untreated Parkinson's Disease (PD) who are at least 40 years old. The study aims to find out if SUL-238 can improve mitochondrial function in the brain, which is related to energy production, and to assess its safety. The research compares two doses of SUL-238 to a placebo to see how well it works by using a special brain scan called 31P-MRS, which is similar to an MRI. Participants will be randomly assigned to one of three groups: high dose SUL-238 (1500 mg three times daily), low dose SUL-238 (500 mg three times daily), or placebo. They will take their assigned treatment orally every day for 28 days, with certain fasting requirements before dosing. The study includes a screening period of up to four weeks, a four-week treatment period, and a four-week follow-up period without dosing. Blood samples and brain scans will be collected at specified intervals during the study to monitor effects. During the study, participants will visit the clinic five times for assessments, blood sampling, and brain imaging. Some participants may also provide cerebrospinal fluid samples. Researchers will monitor mitochondrial-related brain metabolites and systemic markers, track symptoms using diaries, and check safety and tolerability throughout the study and follow-up. The total participation time is approximately eight weeks, including screening, treatment, and follow-up visits.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with untreated Parkinson's Disease according to UK PDS Brain Bank Criteria, showing bradykinesia plus muscular rigidity, rest tremor, or postural instability
- Parkinson's Disease diagnosis within 1 year
- Modified Hoehn and Yahr stage 1.0 or less
- Montreal Cognitive Assessment (MOCA) score of 22 or higher
- Men and women aged 40 years or older at screening
- Able to understand the study and provide written informed consent
- Able to complete all study-related tests and evaluations
- Likely to participate in all scheduled evaluations and comply with study requirements
- Agree to use highly effective contraception if of child-bearing potential; contraception requirements vary by gender
- Women of non-childbearing potential must be post-menopausal or surgically sterile, with a negative pregnancy test before dosing
You will not qualify if you...
- Atypical parkinsonism or other neurodegenerative diseases
- History of intellectual disability or psychiatric disorders except mild resolved depression/anxiety
- Positive responses to certain suicide risk questions at screening
- Positive tests for Hepatitis B, Hepatitis C, or HIV
- Elevated liver enzymes (ALT or AST) above 1.5 times normal
- Use of investigational products or devices recently before study start
- Use of supplements or drugs affecting mitochondrial function within 30 days
- Use of strong CYP3A4 inhibitors or narrow therapeutic index substrates within 30 days
- Known drug allergies or sensitivities contraindicating participation
- Pregnancy, lactation, or planning pregnancy during or shortly after the study
- Conditions affecting drug absorption or metabolism, including cholecystectomy
- Significant abnormalities in heart rhythm or ECG that affect QTc interpretation
- Abnormal blood pressure or heart rate at screening
- Known difficulty swallowing tablets or other compliance issues
- Unwillingness to use birth control if applicable
- Contraindications to undergoing MRI scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants take oral doses of SUL-238 or placebo three times daily for 28 days with fasting before dosing and morning dose only on day 28.
3 visits during treatment period for assessments and blood sample collections (days 1, 14, and 28)
Duration - 4 weeks
Participants are monitored for 4 weeks after treatment to assess safety and study outcomes.
1 visit for end-of-study assessments (day 56)
Trial Site Locations
Total: 1 location
1
CTC Netherlands BV
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
N
Nadir Ulu, MD, PhD
M
Mariska Beukers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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