EMBARGOED FOR RELEASE UNTIL 4 PM ET, April 17, 2012
Clinical Trial: Intestinal Gel Reduces 鈥極ff鈥 Time in Advanced Parkinson鈥檚 Disease
NEW ORLEANS -
A levodopa-carbidopa intestinal gel (LCIG) works better than standard oral levodopa-carbidopa in reducing 鈥渙ff鈥 time in patients with advanced Parkinson鈥檚 disease. That鈥檚 according to results of the phase three randomized, double-blind clinical trial of LCIG, to be presented as part of the Emerging Science program (formerly known as Late-Breaking Science) at the 64th Annual Meeting in New Orleans April 21 to April 28, 2012. 鈥淥ff鈥 time occurs when Parkinson鈥檚 symptoms like tremor, slowness, stiffness and walking difficulty return as the beneficial effects of oral treatments wear off. The intestinal gel contains levodopa and carbidopa, two drugs commonly prescribed for Parkinson鈥檚, and is infused through a portable pump connected to a tube implanted in the intestine, similar to a feeding tube. 鈥樷淥ff鈥 time was reduced because the infusion of LCIG helps to deliver levodopa-carbidopa continuously, thereby avoiding the fluctuating levels that occur with standard oral levodopa-carbidopa therapy and that are thought to contribute to the development of wearing off,鈥 said study author C. Warren Olanow, MD, Professor of Neurology and Neuroscience at the Mount Sinai School of Medicine in New York and a Fellow of the 好色先生. In the three-month double-blind trial, 71 participants were randomized to receive either the continuous infusion of LCIG and dummy pills or a dummy intestinal gel and pills that contained levodopa and carbidopa. At the start of the study, the average person had Parkinson鈥檚 disease for about 11 years and experienced 6.6 hours of 鈥渙ff鈥 time per day. A total of 93 percent of participants completed the study. The study found that the continuous LCIG reduced 鈥榦ff鈥 time by an average of nearly two extra hours per day and improved 鈥渙n鈥 time without troublesome movements by an average of two hours per day compared to people taking standard levodopa-carbidopa. Treatment with LCIG was also not associated with an increase in troublesome dyskinesia. 鈥淟ess 鈥榦ff鈥 time for people with Parkinson鈥檚 means more time during the day in which they can enjoy the benefits of levodopa-carbidopa therapy and experience improved quality of life. We believe that benefits observed with this method of treatment compare favorably with other methods for treatment, such as deep brain stimulation, and avoid the need for an intracranial neurosurgical procedure,鈥 said Olanow. The most common side effects associated with LCIG treatment involved complications due to inserting the device, abdominal pain, pain during the procedure and nausea. The study was supported by Abbott. Learn more about Parkinson鈥檚 disease at .
