Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease
- Conditions
- Parkinson's Disease
- Registration Number
- NCT05894343
- Lead Sponsor
- MeiraGTx, LLC
- Brief Summary
The objective of this study is to evaluate the long-term safety of AAV-GAD delivered bilaterally to the subthalamic nuclei (STN) in participants with Parkinson's disease.
- Detailed Description
The duration of individual participation in this study will be approximately 54 months for participants who received AAV-GAD in Study MGT-GAD-025 and approximately 60 months for participants who received sham surgery in Study MGT-GAD-025.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13
- Previously enrolled in Study MGT-GAD-025.
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants with study drug-related adverse events and serious adverse events From study start until Month 60 post treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Yale University
🇺🇸New Haven, Connecticut, United States
Henry Ford West Bloomfield Hospital
🇺🇸West Bloomfield, Michigan, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Yale University🇺🇸New Haven, Connecticut, United States