Results of multi-center study published in Archives of Neurology
Patients with moderate to advanced Parkinson’s disease who received the experimental drug rasagiline had more functional time during the day compared to those who took a placebo, according to researchers from the Parkinson’s Study Group, an international network that includes University of Maryland physicians. Results from the multi-center trial appear in the February issue of Archives of Neurology.
“Patients taking rasagiline had a significant decrease in their ‘off’ times, which are periods when traditional Parkinson’s medications are not working as well and symptoms return,” explains Lisa Shulman, M.D., associate professor of neurology at the University of Maryland School of Medicine, who was a principal investigator for the study. Dr. Shulman is also co-director of the Maryland Parkinson's Disease and Movement Disorders Center at the University of Maryland Medical Center.
When the study began, patients had an average of six hours of “off” time per day. With the addition of rasagiline, patients gained nearly an hour of functional time per day, depending on the dosage.
“During their ‘off’ times, patients with advanced Parkinson’s disease may have a very difficult time just trying to walk. Other symptoms include tremor, balance problems and speech problems,” says Dr. Shulman. “To many people, an extra hour a day may not sound like much. But if that extra hour allows you to feed yourself, get dressed or just function normally, it makes a big difference.”
The study also showed that the patients had improved motor function during their “on” times, periods when Parkinson’s symptoms were adequately treated. During the study, patients continued taking their other Parkinson’s medications. The trial included 472 patients at 57 sites in the United States and Canada.
“Patients in the study also had very few side effects from the medication,” says William Weiner, M.D., chairman and professor of neurology at the University of Maryland School of Medicine and chief of neurology at the University of Maryland Medical Center.
For the 26-week PRESTO (Parkinson’s Rasagiline Efficacy and Safety in the Treatment of “Off”) study, researchers gave participants a daily dose of one mg rasagiline, 0.5 mg rasagiline or a placebo.
Dr. Weiner adds, “Another benefit for patients is they only need to take the drug once a day. With many Parkinson’s drugs, you have to take them three to six times a day. In this trial, we found that the drug was very simple to take, had few side effects and gave patients an additional hour of functional time on average, per day. So it may be a very useful tool in treating patients with advanced Parkinson’s disease.”
University of Maryland and other Parkinson’s Study Group researchers also found positive results in another rasagiline study. That study, for patients with early Parkinson’s disease, showed that the drug helped patients to maintain function over time.
Results from that study appeared in the April 2004 issue of Archives of Neurology. The Food and Drug Administration will review the findings of these and other studies when deciding whether to give its approval to rasagiline.
Parkinson’s disease affects more than one million people in the United States, about half of whom have moderate to advanced Parkinson’s Disease. Many of these patients experience episodic “off” times and motor fluctuations, despite taking Parkinson’s medications.
The cause of Parkinson’s disease is unknown, but it affects the brain’s ability to produce dopamine, the neurotransmitter involved in communication between the brain cells for motor control. Symptoms include rigidity of the limbs and difficulty initiating movement. Many patients have a tremor that may involve the arms or the legs.
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