Clinical Study of Parkinson's Disease Drug Shows Positive Results

Tuesday, May 04, 2004

Media Contact:
Lynn Closway
Mayo Clinic
480-301-4222
closway.lynn@mayo.edu

For Immediate Release - May 4, 2004

SCOTTSDALE, Ariz. - Results of a major multi-center clinical trial of rasagiline in Parkinson's disease (PD), in which Mayo Clinic was a participant, showed that patients with early Parkinson's disease who were treated with rasagiline for one year had better functional outcomes than patients for whom treatment was delayed for six months. Findings were published in the April issue of the Archives of Neurology.

Charles Adler, M.D., Ph.D., chair of the Mayo Clinic Movement Disorders Center and a neurologist in the Department of Neurology at Mayo Clinic in Scottsdale, says, "Rasagiline is an excellent and exciting new addition to the medications available for treating Parkinson's disease."

Rasagiline, a selective, irreversible, second-generation MAO-B inhibitor was tested in this trial as a single treatment for Parkinson's disease. Research physicians at 32 Parkinson Study Group sites in the United States and Canada evaluated 371 patients with early Parkinson's disease in a 52-week study. Study participants completed evaluations of their symptoms, and investigators assessed the severity of their Parkinson's disease.

The primary outcome measure of the study was the average change in the Total Unified Parkinson's Disease Rating Scale (UPDRS) score. The UPDRS scale is a standardized measure of patients' abilities to perform basic motor skills, as well as the effect of the disease on activities of daily living and mental abilities. As the disease progresses, UPDRS scores increase.

The one-year analysis employed an innovative design known as a "randomized, delayed-start" study whereby one group of patients receives treatment from the beginning of the study, and the other group begins treatment after a delayed period. At the end of the study, all patients are receiving treatment with the active medication. The purpose of this design is to help distinguish between short-term and long-term effects of the experimental medication.

Results showed treatment with rasagiline at doses of 1 mg or 2 mg per day for 12 months was associated with a smaller increase/less worsening in the UPDRS scores compared with patients for whom rasagiline was delayed for 6 months.

Rasagiline was well tolerated in the study. The most commonly observed adverse events in the active treatment phase (occurring in more than five percent of patients) were infection, headache, dizziness, and accidental injury. In no case did an individual adverse event occur significantly more frequently in patients originally assigned to rasagiline than in those originally assigned to placebo.

Mayo Clinic is a private group practice of medicine dedicated to providing diagnosis and treatment of patient illnesses through a systematic focus on individual patient needs. As a leading academic medical center in the Southwest, Mayo Clinic focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 205-bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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