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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

Study category: Brain and Nervous System

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Description

Study is double blind and placebo controlled.

Details
Age

Adult

Eligibility

Parkinson's disease for greater than 4 years, responsive to levodopa, willing to be randomized into the placebo arm, and able to travel out of state for 3 study visits.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Steven Ojemann,  MD

Steven Ojemann, MD

Study ID

Protocol Number: 18-0829

ClinicalTrials.gov: NCT03562494

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