Actively Recruiting
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
Led by GEN İlaç ve Sağlık Ürünleri A.Ş. · Updated on 2026-03-31
45
Participants Needed
1
Research Sites
65 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
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
CONDITIONS
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
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 one of muscular rigidity, rest tremor, or postural instability
- Parkinson's Disease diagnosis made within the last year
- Modified Hoehn and Yahr stage of 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 tests and evaluations
- Able and likely to comply with all scheduled evaluations and tests
- Men and women of child-bearing potential agree to use effective contraception during the study and specified time after
- Women of non-childbearing potential must be post-menopausal or surgically sterile with 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 resolved mild depression or anxiety
- Positive responses indicating suicide risk on screening scale
- Positive tests for Hepatitis B, Hepatitis C, or HIV at screening
- Elevated liver enzymes (ALT or AST) above 1.5 times the normal limit
- Use of investigational products within 90 days before study
- Use of supplements or drugs that affect mitochondrial function or CYP3A4 inhibitors within 30 days before study
- History of drug allergies or sensitivities to study medications
- Pregnancy, breastfeeding, or planning pregnancy during or within 6 months after study
- Diseases or surgeries affecting drug absorption or metabolism, including cholecystectomy
- Significant clinical abnormalities in liver, kidney, heart, lung, endocrine, eye, immune, blood, skin, or neurological systems (other than PD)
- Abnormal ECG findings that interfere with QTc measurement
- Abnormal vital signs including blood pressure and heart rate outside specified limits
- Unlikely to comply with the study or unable to swallow tablets
- Unwillingness to use birth control as required
- Contraindications for MRI procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CTC Netherlands BV
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
N
Nadir Ulu, MD, PhD
CONTACT
M
Mariska Beukers
CONTACT
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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