ong-term observational study of Gene Therapy for Parkinson's disease
Not Applicable
Recruiting
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCT2033220367
- Lead Sponsor
- akajima Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Patients who enrolled in the Phase I/II Study of Gene Therapy for Parkinson's disease, and who completed or discontinued the study.
Exclusion Criteria
-Patients who cannot undergo MRI.
-Individuals who wish to have children, but do not cryopreserve sperm or eggs prior to administration of the investigational product and use them to obtain children.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the long-term tolerability, safety, and efficacy of the study product in patients with Parkinson's disease, after intracerebral administrations of AAV-hAADC-2 into the putamen.
- Secondary Outcome Measures
Name Time Method