Long Term Follow-Up Study for rAAV-GAD Treated Subjects
- Conditions
- Parkinson's Disease
- Registration Number
- NCT01301573
- Lead Sponsor
- Neurologix, Inc.
- Brief Summary
The purpose of this observational study is the long term follow-up of Parkinson's patients who participated in a clinical trial in which they received AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and provide long term safety information.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
- Participated in a clinical trial where they received AAV-GAD
- Able to give informed consent to participate in the study
- Received Deep Brain Stimulation after receiving AAV-GAD
- Received any experimental device in the brain after receiving AAV-GAD
- Had any type of brain surgery after receiving AAV-GAD
- Received any experimental therapy (drug or biologic) for Parkinson's disease or any other indication after receiving AAV-GAD
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Stanford University
🇺🇸Stanford, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Health Systems
🇺🇸Southfield, Michigan, United States
Wake Forest University Health Science Center
🇺🇸Winston-Salem, North Carolina, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Stanford University🇺🇸Stanford, California, United States