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
Plain-Language Summary
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.