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

    • Blake’s Story: Medulloblastoma

      Blake's Story: Medulloblastoma Blake knew he was in the right hands the moment he saw the surgeon’s wrists. Dr. John M. Tew, Blake’s neurosurgeon, was wearing one of Lance Armstrong’s yellow LiveStrong cancer bracelets. So was Blake. Dr. Tew, who was also sporting...
    • 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...
    • Norma’s Story: Essential Tremor

      Norma's Story: Essential TremorQuestion: what progressive neurological condition causes a rhythmic trembling of the head, voice, legs or trunk; can be treated with medication or deep brain stimulation; has no definitive cure; and is eight times more common than Parkinson’s disease? If you’re...
    • 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...
    • Ameer’s Story: Pituitary Tumor

      Ameer's Story: Pituitary Tumor Ameer’s friends noticed the weight loss, and they kept asking him  about it. Was he OK? Ameer wasn’t concerned at first. Then he began to  notice that he couldn’t see people approaching him from the side. His  peripheral vision was...
    • 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....
    • Dr. Mike’s Story: Glioblastoma

      Dr. Mike's Story: Glioblastoma Sixteen months after receiving a diagnosis of brain cancer, Dr. Michael Wood continues to attack his disease with wellness. In addition to surgery, radiation, chemotherapy and strong family support, the 61-year-old Cincinnati otolaryngologist has worked hard to provide his own...
    • Courtney’s Story: Traumatic Spine Injury

      Courtney's Story: Traumatic Spine Injury Courtney is positive that she was wearing her seatbelt. Perhaps that is why her head and neck – thankfully -- were fine. Perhaps that is also why her midsection was so violently impacted, as the force of the rollover twisted...
    • John’s Story: Epilepsy

      John's Story: Epilepsy In golf they call it a “bad lie.” A golfer strikes the ball, hoping to place it in a comfortable location on the fairway or the green, but the ball winds up somewhere else entirely – on the side of a...
    • 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...