Trials / Completed
CompletedNCT05822739
Safety and Efficacy Study of Parkinson's Disease Gene Therapy Drug (BBM-P002)
A Single-Arm, Open-Label, Exploratory Clinical Study of BBM-P002 Gene Therapy for Parkinson's Disease
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Xiangya Hospital of Central South University · Academic / Other
- Sex
- All
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Safety and Efficacy Study of BBM-P002 in participants with primary advanced Parkinson's disease
Detailed description
Parkinson's disease is a neurodegenerative disorder involving loss of dopaminergic neurons in the substantia nigra. This study is a single-center, single-arm, open-label, treatment clinical study to evaluate the safety, tolerability and efficacy of an adeno-associated virus (AAV)-based gene therapy, termed BBM-P002, will be injected into the brain via a neurosurgical procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BBM-P002 | Genetic: single- dose intracranial injection of BBM-P002 Neurosurgical delivery of BBM-P002 to the brain |
Timeline
- Start date
- 2023-04-14
- Primary completion
- 2025-10-30
- Completion
- 2025-10-30
- First posted
- 2023-04-21
- Last updated
- 2026-01-15
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05822739. Inclusion in this directory is not an endorsement.