Phase 2 Study of Oral SUL-238 Drug Effects on Brain Energy in Early, Untreated Parkinsons Disease Using Magnetic Resonance Spectroscopy

What this Trial Is About

Researchers are studying the effects of a new drug called SUL-238 on patients with early, untreated Parkinsons 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.

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