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13th June 2011 - News release

LCIG CLINICAL TRIAL DATA FOR PARKINSON'S DISEASE

Abbott have provided details of a Phase 3 clinical trial of LCIG in Parkinson's Disease. LCIG is levodopa-carbidopa intestinal gel. Levodopa-carbidopa is the same combination used in Sinemet. LCIG is infused directly and continuously during daytime hours into the small intestine via a portable pump connected to a surgically-implanted gastric tube. It was thought that continuous delivery may help reduce peaks in drug levels due to the inconsistent absorption that happens with orally consumed drugs. After 12 weeks in to the 54 week trial, patients reported an average of 3.9 fewer hours of "off" time and 4.6 more hours of "on" time without dyskinesias. Self reporting after surgery is very prone to placebo effect, yet figures for a placebo were not provided, thus preventing an assessment of how much actual improvement there was beyond that of a placebo.

Adverse events occurred in 87% of patients, and appeared to be largely related to the surgical procedure. The most common adverse events were : abdominal pain (30%), complications of device insertion (21%), procedural pain (17%), constipation (13%), nausea (13%), excessive granulation tissue (13%), fall (10%), dyskinesia (10%), insomnia (10%), post-operative wound infection (10%), and anxiety (10%). The most severe complications from surgery were : abdominal inflammation (3%),  and gas or air in the peritoneal cavity (5%). For more information go to the News release. For more current news go to Parkinson's Disease News.

 

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Parkinson's Disease News details all significant new research, news reports, new books, and new resources concerning Parkinson's Disease and those medical disorders that often coincide with Parkinson's Disease. It is compiled from an analysis of  all newly published research, news reports, new clinical trials, all newly published books, and new web sites. A summary and analysis of the new research are provided,  as well as links to the complete abstracts and news reports

                                    

 

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