Restore dopamine to improve movement
- Trial ID
- NCT06753331
- Official Title
- A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses Following Stereotactic Intracranial Implantation of DSP-1083 Into Subjects With Parkinson's Disease
- Goal
- Restore dopamine to improve movement
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- Sumitomo Pharma America, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 25 participants
- Conditions
- Parkinson's Disease
- Interventions
- DSP-1083 implantation, Sham surgery treatment
Summary For Families
The goal is to test whether implanting DSP-1083 cells into movement-related brain areas can safely engraft and improve motor symptoms by restoring dopamine function in people whose Parkinson's is not well controlled on meds. The approach is stereotactic brain surgery to place a cell therapy product, with a randomized sham surgery control so researchers can compare safety and clinical responses; the implanted cells are intended to survive and replace or support dopamine-producing neurons while participants remain on their usual levodopa regimen so changes in medication response can be assessed. The trial is looking for adults 40 to 72 years old with a clinical PD diagnosis for at least 4 years, a clear levodopa response, suboptimal control despite stable levodopa-based therapy, moderate off-state disability, and no prior DBS, ablation, or other implanted brain therapies.
Locations
- University of Kentucky Medical Center, Lexington, Kentucky, United States
- New York Presbyterian Hospital-Columbia University Medical Center, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DSP-1083 implantation. The goal is to test whether implanting DSP-1083 cells into movement-related brain areas can safely engraft and improve motor symptoms by restoring dopamine function in people whose Parkinson's is not well controlled on meds. The approach is stereotactic brain surgery to place a cell therapy product, with a randomized sham surgery control so researchers can compare safety and clinical responses; the implanted cells are intended to survive and replace or support dopamine-producing neurons while participants remain on their usual levodopa regimen so changes in medication response can be assessed. The trial is looking for adults 40 to 72 years old with a clinical PD diagnosis for at least 4 years, a clear levodopa response, suboptimal control despite stable levodopa-based therapy, moderate off-state disability, and no prior DBS, ablation, or other implanted brain therapies.
- Who can participate?
- Participants must be between 40 Years and 72 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 1/Phase 2 trial is estimated to last approximately 6 years.
- 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.