What is the Purpose of this Study?
The purpose of this study is to compare the effects of an experimental drug called prasinezumab with placebo (inactive substance) in patients with early-stage Parkinson’s disease who are taking a drug called levodopa to manage their disease symptoms. Prasinezumab is a type of medication called a monoclonal antibody. Monoclonal antibodies are laboratory-made proteins that have been engineered to recognize and bind to a specific type of protein. Prasinezumab binds to a protein called α-synuclein. In people with Parkinson’s disease, α-synuclein clumps together inside brain cells, causing the cells to become unhealthy. Prasinezumab may clear away harmful forms of α-synuclein to prevent damage to brain cells, potentially slowing the course of Parkinson’s disease. Participants will be randomly assigned to receive either prasinezumab or placebo. All participants may then have the opportunity to receive prasinezumab in an extension phase of the study. The main purpose of the extension will be to provide treatment for participants and study the safety and tolerability of prasinezumab over a longer period of time.
Eligibility
- * Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
- * Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
- * Has received monotherapy treatment
- * An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY-STAGE PARKINSON'S DISEASE