BN44715 PRASINEZUMAB IN EARLY-STAGE PARKINSON’S DISEASE
Research type
Research Study
Full title
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
IRAS ID
1012797
Contact name
Ethan Montenegro
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Research summary
Parkinson’s disease (PD) is a long-term condition that gets worse over time. In PD, a naturally occurring protein called alpha-synuclein does not form properly. It sticks together to form clumps. This damages nerve cells in certain areas of the brain and causes nerve cells to die. Some of these nerve cells are responsible for the production of a chemical called ‘dopamine’, which is important for controlling movement. The damage to nerve cells leads to a lack of dopamine in the brain causing movement-related (motor) and non-motor symptoms. Current treatments relieve symptoms but do not reverse, slow down or stop brain cells from dying. Medicines that replace dopamine are mainly used. As the disease gets worse, these medicines become less effective at controlling symptoms. New medicines are needed that can prevent brain cell death to stop or slow the speed at which PD gets worse. This study is testing a medicine called prasinezumab. It is being developed to slow down the progression of PD symptoms. Prasinezumab is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved prasinezumab for the treatment of PD. This study aims to compare the effects of prasinezumab against non-active medicine (placebo) in people with PD who are taking levodopa to manage their symptoms. Total time of participation in the study will likely be between 2 and about 3.5 years depending on when they join.
There will be approximately 25 patients recruited at 6 UK sites
The study is sponsored by F. Hoffmann- La Roche
Research Summary; Version 1 and 23-07-2025;REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0259
Date of REC Opinion
24 Sep 2025
REC opinion
Further Information Favourable Opinion