A Randomized Placebo Surgery Controlled Double-blinded Multi-center Phase 2 Clinical Trial Evaluating the Efficacy and Safety of VY-AADC02 in Advanced Parkinson's Disease with Motor Fluctuations

Brief description of study

The purpose of this study is to evaluate the safety and effectiveness of an experimental product called VY-AADC02 on the severity of Parkinson's disease symptoms. An experimental product is one that is being tested and is not approved by the United States Food and Drug Administration (FDA). VY-AADC02 (the study product) involves placing a gene in the brain (through surgery) and the gene then would program brain cells to produce an enzyme (protein) called aromatic amino acid decarboxylase (AADC). AADC is a naturally occurring protein found in the brain that changes levodopa (one of your current PD medications) to dopamine. Dopamine is a chemical involved with the normal function of movement control centers in the brain. As PD worsens, the amount of AADC in the brain decreases which lowers the amount of dopamine that is produced from each dose of levodopa that is taken.

Clinical Study Identifier: s17-01749
ClinicalTrials.gov Identifier: NCT03065192
Principal Investigator: Andrew S. Feigin
Currently Recruiting

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