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NIH Announces Phase III Clinical Trial of Creatine for Parkinson's Disease

The NIH National Institute of Neurological Disorders and Stroke (NINDS) today is launching a large-scale clinical trial to learn if the nutritional supplement creatine// can slow the progression of Parkinson's disease (PD). While creatine is not an approved therapy for PD or any other condition, it is widely thought to improve exercise performance. The potential benefit of creatine for PD was identified by Parkinson’s researchers through a new rapid method for screening potential compounds.

The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. It will enroll 1720 people with early-stage PD at 51 medical centers in the United States and Canada.

"This study is an important step toward developing a therapy that could change the course of this devastating disease," says Elias A. Zerhouni, M.D., director of the NIH. "The goal is to improve the quality of life for people with Parkinson's for a longer period of time than is possible with existing therapies." Currently there is no treatment that has been shown to slow the progression of PD.

The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's Disease). NINDS has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process—from laboratory research to pilot studies in a select group of patients, to the definitive phase III trial of effectiveness in people with Parkinson’s disease.

"This study is an example of the Institute's commitment to Parkinson's research," says NINDS director Story C. Landis, Ph.D. "We are trying to explore every possible option for reducing the burden of this disease."

Participants will be in the phase III study for five to seven years. The effort will be led
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