Results of a clinical trial at Mayo Clinic Scottsdale and other sites may give new hope to Parkinson’s patients in the early stages of the disease.
Researchers found the drug rasagiline provides symptom relief for Parkinson’s patients and may slow progression of the disease. It is being considered for approval by the U.S. Food and Drug Administration.
"This study is the pivotal study that the FDA is using to determine whether it is going to approve the drug for release," said researcher Dr. Charles Adler, chairman of the Mayo Clinic Division of Movement Disorders.
Results of the study were published in the April issue of Archives of Neurology.
Rasagiline was tested on 371 patients across the United States and Canada in a one-year study, with seven patients taking part at Mayo Clinic Scottsdale. The first patients enrolled in 1997, with the last patient finishing in June 2000.
Many of the patients have continued taking the drug, and researchers are monitoring their progress, Adler said.
Rasagiline was developed as an improvement of the drug selegiline, used to treat Parkinson’s symptoms, said Dr. Richard Burns of Barrow Neurological Institute in Phoenix. The institute has also studied rasagiline in Parkinson’s patients.
In the clinical trial, researchers learned the drug not only gave symptom relief, but also appeared to have neuroprotective effects: It slowed progression of the disease, Burns said.
"I think what (rasagiline) adds for us is another drug to use early in the treatment of Parkinson’s patients, with the hope of potentially slowing the disease’s progress," Adler said.
Patients experienced improved movement speed, reductions in tremor and less rigidity.
Research showed the drug slowed progression of disability in patients, but it is unclear whether it just provided symptom relief or actually slowed nerve cell death, Adler said.
The drug’s most common side effects were headaches and dizziness, but the drug was well-tolerated overall, according to the study.
Burns said most specialists in movement disorders look forward to the response in patients once the drug becomes available for widespread use.