The study was released April 17 and will be presented next week at the American Academy of Neurology's annual meeting in New Orleans.
In his study, 71 participants received either the continuous infusion of the gel and inactive placebo pills or an inactive gel and pills that contained levodopa-carbidopa. When the three-month study began, the average participant had Parkinson's disease for about 11 years and experienced 6.6 hours of "off" time every day.
Those who received the gel reduced their "off" time by about nearly two extra hours per day and their "on" time -- or time spent without movements -- increased by an average of two hours per day, compared to those who took levodopa and carbidopa in pill form, the researchers reported. The most common side effects with the gel were related to complications inserting the device, abdominal pain, pain during the procedure and nausea.
The plan is submit the current data to the U.S. Food and Drug Administration for approval. The study was supported by Abbott Laboratories, the company developing the new intestinal gel.
"It sounds like a good option for people with advanced Parkinson's disease," said Dr. Roy Alcalay, an assistant professor of neurology at Columbia University Medical Center in New York City, and an adviser for the Parkinson's Disease Foundation. "The indications are similar to those of the brain surgery [known as deep brain stimulation], and may be good for people who do not want the surgery or those who still have a lot of symptoms and medication side effects after surgery," he said.
"The drug seems to work well, but the major concern with the drug is the problems around its administration, which include an abdominal procedure done by a gastroenterologist," he added.
Findings presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.
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