Brain injection reduces movement problems
- Trial ID
- NCT07195825
- Official Title
- A Single-arm, Open-label, Single-dose Clinical Study to Evaluate the Safety and Tolerability of BBM-P002 for Stereotactic Bilateral Putamen Injection in the Treatment of Idiopathic Parkinson's Disease
- Goal
- Brain injection reduces movement problems
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Shanghai Xinzhi BioMed Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 18 participants
- Conditions
- PD
- Interventions
- Injecting BBM-P002 into the bilateral putamen
Summary For Families
The goal is to test the safety and tolerability of a one-time, stereotactic bilateral putamen injection of BBM-P002 in people with idiopathic Parkinson's, by delivering the therapy directly into the brain region that controls movement to potentially reduce motor problems. BBM-P002 is given as a single targeted dose into both putamina so it acts locally on the tissues that manage motor function, and participants remain on a stable dose of levodopa or other dopamine-releasing meds so investigators can see how the brain injection behaves alongside standard treatment. This Phase 1, open-label trial plans about 18 participants, ages 40 to 70, who have had Parkinson's for at least five years and show a positive levodopa response. People with major cognitive impairment, contraindications to brain surgery or prior brain surgery, serious medical or lab abnormalities, recent gene or stem-cell or other investigational treatments, pregnancy, or active infections are excluded.
Locations
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Injecting BBM-P002 into the bilateral putamen. The goal is to test the safety and tolerability of a one-time, stereotactic bilateral putamen injection of BBM-P002 in people with idiopathic Parkinson's, by delivering the therapy directly into the brain region that controls movement to potentially reduce motor problems. BBM-P002 is given as a single targeted dose into both putamina so it acts locally on the tissues that manage motor function, and participants remain on a stable dose of levodopa or other dopamine-releasing meds so investigators can see how the brain injection behaves alongside standard treatment. This Phase 1, open-label trial plans about 18 participants, ages 40 to 70, who have had Parkinson's for at least five years and show a positive levodopa response. People with major cognitive impairment, contraindications to brain surgery or prior brain surgery, serious medical or lab abnormalities, recent gene or stem-cell or other investigational treatments, pregnancy, or active infections are excluded.
- Who can participate?
- Participants must be between 40 Years and 70 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 1 trial is estimated to last approximately 2 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.