Expired Study
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Clinical Trial 4418

FL 32827

Study Summary:

This study will test if an experimental treatment for Parkinson’s disease (PD) is safe and if it will help reduce the motor symptoms of Parkinson’s disease, including tremor, gait disorder, motor fluctuations, and dyskinesias (involuntary movements).

This study will evaluate an experimental treatment called gene transfer. Gene transfer is a way of placing genetic material (genes) into a person. The gene transfer product in this study uses parts of a virus called adeno-associated virus (AAV), which delivers the gene. The genes of the virus that make it active have been removed and have been replaced with the GAD gene.

This is a double-blind, randomized, placebo controlled study. This means both the study doctor and the participant will not know what treatment was given (double-blind). The placebo in this study is saline (sterile salt water solution). Whether a participant receives rAAV-GAD or saline will be decided by chance, like flipping a coin (randomized).

In this study, the sterile saline or rAAV-GAD will be placed into a part of the brain called the subthalamic nucleus (STN). The STN is overactive in people with PD. Placing the GAD gene into the STN may make the STN less overactive and may improve motor related symptoms.

To register for a Webcast that will provide information about the experimental treatment and the clinical trial, go to http://www.neurologixpdtrial.com/.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.