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

Share

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 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 contact kristy.sullivan@uc.edu or call (513) 558-6517.

This entry was posted in UC Neuroscience Blog and tagged . Bookmark the permalink. Both comments and trackbacks are currently closed.
  • Print This Page
  • Make an Appointment: Schedule Now
  • UCNI Weekly Blog
  • Join Our Email List
    for Bi-Monthly Updates

    Click here to continue.
  • Hope Stories

    • Joe’s Story: Oligodendroglioma

      Joe's Story: Oligodendroglioma Joe calls it a miracle and a gift from “a higher power.” Others might call it a fortuitous turn of fate. Either way, Joe’s experience embodies a reversal of fortune that is both wonderful and startling. Once a man with...
    • Kevin’s Story: Acoustic Neuroma

      Kevin's Story: Acoustic Neuroma Kevin was in his mid-40s when he began to notice that he wasn’t hearing quite as well as in the past. But the change was gradual, so he didn’t worry about it. A few years went by, and the hearing...
    • Brian’s Story: Vocal Cord Cyst

      Brian's Story: Vocal Cord Cyst One by one, the symptoms of a throat problem tapped on the pastor’s door. Pastor Brian Tome, leader of Crossroads Church and speaker of five weekly messages to a following of 15,000, acknowledged the symptoms and tried to dismiss them....
    • Jim’s Story: Pituitary Tumor

      Jim's Story: Pituitary Tumor One turn of events led to another, and so it was that Jim, and not his wife, took Jim’s 87-year-old father to his appointment with the dermatologist for the first time. And so it was that the dermatologist was not...
    • Rick’s Story: Epilepsy

      Rick's Story: Epilepsy Rick’s strategy for managing his epilepsy wasn’t perfect, but it had worked well enough for most of his career as a theme park project manager who traveled the world. Whether he worked in Australia, Malaysia, Singapore or Germany, his routine...
    • Frank’s Story: Parkinson’s Disease

      Frank's Story: Parkinson's DiseaseSome people have vacation homes. Frank has the UC Neuroscience Institute. This is where he comes for comprehensive, compassionate medical care for Parkinson’s disease, which he has lived with for 15 years. “They make us feel safe,” says Frank’s wife, Sandy....
    • Matt’s Story: Head Injury

      Matt's Story: Head Injury A poor decision nearly cost Matt his life. But state-of-the-art neurosurgical and neurocritical care, dedicated therapists, and family support gave him a chance to start over again. Today, in what is proving to his best decision ever, Matt is studying...
    • Charles Sabine’s Story: Huntington’s Disease

      Charles Sabine's Story: Huntington's DiseaseIn 2005 the NBC war correspondent Charles Sabine made the life-altering decision to face up to his family history of Huntington’s disease and undergo genetic testing. The odds, he knew, were 50-50 that he, too, had the gene and would...
    • Amber’s Story: Ruptured Aneurysm

      Amber's Story: Ruptured Aneurysm The only visible sign of Amber Gray’s ordeal is the long slender scar   that runs along her forearm. It is the area where a surgeon carefully   removed her radial artery, which was needed to bypass a damaged artery   in her...
    • Richard’s Story: Ruptured Aneurysms

      Richard's Story: Ruptured Aneurysms Almost three years ago, Richard “Dick” Watson, MD, found himself in an unfamiliar position for a doctor: lying on the operating table instead of standing over it. He didn’t know it at the time, but it was the beginning of...