An extension study for participants who have completed a prior VY-AADC01 clinical study
Study Type
OBSERVATIONAL
Enrollment
14
University of California, San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Ohio State University
Columbus, Ohio, United States
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Long-term safety of VY-AADC01 as measured by Adverse Events and Serious Adverse Events
Time frame: Up to 8 years from VY-AADC01 administration
Change in AADC enzyme activity
Continued expression of AADC as measured by \[18F\]-fluorodopa (F-Dopa) positron emission tomography (PET)
Time frame: Up to 8 years from VY-AADC01 administration
Changes in PD medications
Change from baseline in PD medications, measured as levodopa equivalent dose
Time frame: Up to 8 years from VY-AADC01 administration
Changes in motor function as assessed by Unified Parkinson's Disease Rating Scale (UPDRS)
Changes from baseline in motor function as assessed by UPDRS, in both "Off" and "On" medication states
Time frame: Up to 8 years from VY-AADC01 administration
Changes in "Off" and "On" time as recorded by the participant in Parkinson's Disease (PD) diary
Changes from baseline based on the PD Diary: "OFF" time; "ON" time without troublesome dyskinesia; "ON" time without dyskinesia; "ON" time with troublesome dyskinesia; and "ON" time with non-troublesome dyskinesia
Time frame: Up to 8 years from VY-AADC01 administration
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