Largest-ever Parkinson's disease trials

Researchers with the National Institute of Neurological Disorders and Stroke (NINDS) have initiated one of the largest-ever Parkinson's disease clinical trials.

The study, which involves more than 50 sites and will enroll over 1,700 patients in the U.S. and Canada, is intended to test a new drug therapy, developed by Palo Alto-based Avicena Group, to slow the progress of Parkinson's disease and help millions of people around the world afflicted with this debilitating disease.

"This study will harness the expertise of some of the top researchers in the country," says Dr. Karl Kieburtz, lead investigator for the study. "Projects like this are evidence of the scientific and business communities' commitment and willingness to collaborate to improve the lives of Parkinson's patients."

Despite the large patient population, and high profile sufferers including Muhammad Ali, Michael J. Fox and Janet Reno, current drugs can only treat the disease symptoms. None has been shown to slow or halt disease progression.

The NINDS-sponsored study will examine the efficacy and safety of PD-02, which has demonstrated the potential to improve neurological function and to slow disease progression in Parkinson's patients.

Parkinson's disease belongs to a group of conditions called movement disorders. Some of the common symptoms of Parkinson's are tremors of the hands, arms, legs and jaw, rigidity or stiffness of the body, slowness of movement, and impaired balance and coordination. Because Parkinson's is a chronic disease symptoms worsen over time.

According to the Parkinson's Disease Foundation, approximately 40,000 new cases of Parkinson's are diagnosed each year in the United States with as many as one and a half million people suffering from the disease in total. Individuals eligible for the NIH study are those who have been diagnosed with Parkinson's within the past five years, and have received and been responsive to therapy in the past three months to two years. This trial is the first in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Studies in Parkinson's Disease).