Alberto Espay Presents Promising Interim Results of Phase III Parkinson’s Study

Alberto Espay, MD, examines John, who had recently undergone surgery as part of the Phase III Levodopa-Carbidopa Intestinal Gel clinical trial at UC Health University Hospital. Photo by Cindy Starr / Mayfield Clinic

Alberto Espay, MD, Director of Clinical Research at the James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders, on Thursday presented promising preliminary results of an ongoing, multi-site study of a continuous medication-delivery system for people with Parkinson’s disease. The delivery system is designed to reduce the severe on-again-off-again fluctuations that patients normally experience when taking levodopa orally, and at intervals, throughout the day.

Dr. Espay presented the early results from the 54-month, Phase III clinical trial of Abbott’s Levodopa-Carbidopa Intestinal Gel (LCIG) treatment system at the International Congress of Parkinson’s Disease and Movement Disorders in Toronto. Dr. Espay, an Assistant Professor of Neurology at UC, is a lead investigator in the clinical trial, whose study sites include the the UC Gardner Neuroscience Institute at University Hospital.

Patients participating in the study receive levodopa, which boosts dopamine in the brain, through a tube that leads directly into the duodenum, the first part of the small intestine. The medication is suspended as a stable gel from a cassette worn outside the body (photo below).

A news release from Abbott stated that patients reported improvement in motor symptoms after 12 weeks of treatment with the intestinal gel. They experienced a decrease in “off” time (a re-emergence of symptoms when medication is not working) and an increase in “on” time without dyskinesias, the involuntary movements associated with most treatments used to manage the disease.

“With advanced Parkinson’s disease, the goal of treatment is to provide patients with as much “on” time as possible, while limiting the troublesome dyskinesias they may experience,” Dr. Espay said in the news release. “The interim data from this study of LCIG show clinically meaningful improvements in these important measures.”

The interim report was based on data from 192 patients with advanced Parkinson’s disease who had completed 12 weeks of treatment with LCIG for 16 hours per day. Eleven of those 192 patients were treated by Dr. Espay’s team at the Gardner Center and University Hospital.

At 12 weeks, patients reported an average of 3.9 fewer hours of “off” time and 4.6 additional hours of “on” time without troublesome dyskinesias. Adverse events occurred in 168 patients (87.5 percent) and appeared to be largely related to the surgical procedure. Adverse events included abdominal pain (30.7 percent), complications of device insertion (21.4 percent) and procedural pain (17.7 percent).  The most severe complications from surgery were peritonitis (abdominal inflammation, 3.6 percent) and pneumoperitoneum (gas or air in the peritoneal cavity, 5.7 percent).  Fourteen patients (7.3 percent) withdrew because of an adverse event.

For more information about the Cincinnati portion of the study, please call (513) 558-6517.

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