VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)

Inclusion criteria

• . Males and females, 40 to 75 years of age (inclusive)
• . Diagnosis of PD, consistent with United Kingdom Brain Bank Criteria
• . Motor responsiveness to dopaminergic therapy, demonstrated by improvement in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS III score)
• . Disease duration from diagnosis of ≥4 years
• . An average of ≥3 hours of OFF time (that is, periods of insufficient control of motor PD symptoms) per day over 3 consecutive days as confirmed by the PD Diary
• . A stable, optimal regimen of Parkinson's medications including levodopa for at least weeks prior to screening evaluation. Participants must have a minimum duration of levodopa treatment of ≥1 year
• . In the judgment of the Investigator, stable Parkinson's features and symptoms for at least 4 weeks prior to screening evaluation
• . Agrees to defer any elective neurological surgery, including deep brain stimulation or ablation procedure for PD, levodopa or apomorphine infusion, or the addition of new dopaminergic formulations until after the study is completed, if medically appropriate

Exclusion criteria