New medication improves brain energy
- Trial ID
- NCT07322887
- Official Title
- A Phase 2, Randomized, Double-blind, Placebo-Controlled, Single-Center Study to Assess the Effects of SUL-238 on High Energy Phosphates With Magnetic Resonance Spectroscopy (³¹P-MRS) in Patients With Early, Untreated Parkinson's Disease ("SHEPHERD" STUDY)
- Goal
- New medication improves brain energy
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- GEN İlaç ve Sağlık Ürünleri A.Ş.
- Study Type
- INTERVENTIONAL
- Enrollment
- 45 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- SUL-238 (1500 mg t.i.d.) film-coated tablets, SUL-238 (500 mg t.i.d.) film-coated tablets, Placebo
Plain-Language Summary
The goal is to see whether SUL-238 can improve brain energy metabolism in very early Parkinson's by raising high-energy phosphates like ATP and phosphocreatine, which could help protect neurons or slow early dysfunction. SUL-238 is an oral drug given three times a day at either 500 mg or 1500 mg per dose, it is designed to boost mitochondrial energy production and the study measures those changes using 31P magnetic resonance spectroscopy, and participants are compared to placebo. Because the study enrolls people who are not yet on Parkinson's medications, effects in combination with levodopa are not being tested here. The trial seeks adults aged 40 and older with untreated PD diagnosed within the past year, very mild symptoms (Hoehn and Yahr ≤1), MoCA score ≥22, able to have an MRI, and willing to avoid certain mitochondrial supplements and pregnancy during the study.
Locations
- CTC Netherlands BV, Groningen, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying SUL-238 (1500 mg t.i.d.) film-coated tablets. The goal is to see whether SUL-238 can improve brain energy metabolism in very early Parkinson's by raising high-energy phosphates like ATP and phosphocreatine, which could help protect neurons or slow early dysfunction. SUL-238 is an oral drug given three times a day at either 500 mg or 1500 mg per dose, it is designed to boost mitochondrial energy production and the study measures those changes using 31P magnetic resonance spectroscopy, and participants are compared to placebo. Because the study enrolls people who are not yet on Parkinson's medications, effects in combination with levodopa are not being tested here. The trial seeks adults aged 40 and older with untreated PD diagnosed within the past year, very mild symptoms (Hoehn and Yahr ≤1), MoCA score ≥22, able to have an MRI, and willing to avoid certain mitochondrial supplements and pregnancy during the study.
- Who can participate?
- Participants must be at least 40 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 1 year.