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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.