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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.
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
Published on BioPortfolio: 2014-08-27T03:19:00-0400
The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 [AAV2]-neurturin [NTN]) is effective and safe in the treatment of patients with i...
The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells i...
This is a Phase I dose escalating open-label study designed to assess the safety, tolerability and biologic activity of an in vivo AAV2 mediated delivery of the gene encoding NTN (CERE-120...
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A glial cell line-derived neurotrophic factor ligand that is specific for the GFRA2 RECEPTOR. Neurturin is essential for the development of specific postganglionic parasympathetic NEURONS.
A genus of the family PARVOVIRIDAE, subfamily PARVOVIRINAE, which are dependent on a coinfection with helper adenoviruses or herpesviruses for their efficient replication. The type species is Adeno-associated virus 2.
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