Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease

2014-08-27 03:19:00 | BioPortfolio


The purpose of this study is to evaluate the safety and potential benefits of CERE-120 in the treatment of Parkinson's disease. CERE-120 is an experimental drug that is designed to help damaged nerve cells in the brain function better. CERE-120 employs a virus to transfer the gene that makes neurturin, a protein that may make nerve cells in the brain healthier and protect them from dying. CERE-120 is administered during a neurosurgical procedure. The virus used in CERE-120 is not know to cause disease in people. CERE-120 has been carefully studied in laboratory animals and is in the early stages of being tested in people.

Approximately sixty patients with Parkinson's disease will participate in this study. The first part of the study is designed to evaluate the safety of two different doses of CERE-120. Six subjects will participate in this part of the study, all of whom will receive CERE-120. The second part of the study will provide more information about the safety of CERE-120 and also evaluate if it is beneficial in the treatment of Parkinson's disease. In this portion of the study, half of the subjects will receive CERE-120 and the other half will undergo a "placebo" surgery where no medication will be injected. Participants in both phases of the study will be followed for three years after surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Idiopathic Parkinson's Disease


CERE-120: Adeno-Associated Virus Delivery of Neurturin, Sham Surgery


University of Alabama at Birmingham
United States





Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:19:00-0400

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