About this trial
The purpose of the study is to evaluate the safety and tolerability of BBM-P002 for stereotactic injection to treat participants with idiopathic Parkinson's Disease (PD) during the dose-limiting toxicity (DLT) observation period.
Eligibility criteria
Qualifiers
Participants with a diagnosis of Parkinson's disease for ≥ 5 years.
The Hoehn-Yahr staging meets the requirements during the OFF periods.
The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive
During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly
Disqualifiers
Atypical or secondary Parkinsonism
Have contraindications for surgery or have previously undergone brain surgery
The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease
Those with severe cognitive impairments
Trial design
Treatments tested in this trial
- Injecting BBM-P002 into the bilateral putamen