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

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

Summary

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

Conditions

Idiopathic Parkinson's Disease

Intervention

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

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
10029

Status

Recruiting

Source

Ceregene

Results (where available)

View Results

Links

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

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Medical and Biotech [MESH] Definitions

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.

The care of a fetus or newborn given before, during, and after delivery from the 28th week of gestation through the 7th day after delivery.

An adenoma containing fibrous tissue. It should be differentiated from ADENOFIBROMA which is a tumor composed of connective tissue (fibroma) containing glandular (adeno-) structures. (From Dorland, 27th ed)

Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.

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