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

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

NCT Number	NCT07322887
Lead Sponsor	GEN İlaç ve Sağlık Ürünleri A.Ş. Collaborators: Sulfateq B.V.
Conditions	Parkinson's Disease (PD)
Enrollment	45 participants
Start Date	2026-03-02
Primary Completion	2027-03-01 (estimated)
Study Completion	2027-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-31