Janis’s Story: Parkinson’s Disease

When Janis Yelton gratefully enrolled in a ground-breaking study at the University of Cincinnati Neuroscience Institute, one of four institutes of the UC College of Medicine and UC Health, she was wracked by pain from advanced Parkinson’s disease, taking 32 pills a day, and no longer able to work.

Four years later, Janis still cries when she tells her story about the new treatment option that “saved my life.”

Equally important, the results of the multi-site, Phase 3 clinical trial have been published. The study demonstrated the effectiveness of a constant infusion of Parkinson’s disease medications in gel form through a surgically implanted tube into the upper intestine, or duodenum. Alberto Espay, MD, a study author and Clinical Research Director at the James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders, said that FDA approval of the treatment is anticipated soon.

The clinical trial, funded by AbbVie (formerly part of Abbott), investigated a new delivery system of levodopa for patients with advanced Parkinson’s disease. When patients normally take levodopa orally, multiple times a day, it leads to the stimulation of dopamine receptors in the brain in a cyclic, rather than sustained, fashion. “The new system,” Dr. Espay said, “bathes the patient’s brain in dopamine at all times, which is what normally occurs in a healthy individual. This gives patients the continuity of stimulation of dopamine receptors and, therefore, more stability of function.”

All study participants underwent a procedure to implant a duodenal tube and received either 1) medication-infused gel and placebo pills or 2) pills with real medication and a placebo gel. The gel formulation, calculated and mixed by investigators who were “blinded” to participants’ allocation, was pumped continuously during the waking hours. The study found that participants who received the medications in gel form experienced the greatest decrease in the number of hours with disabling symptoms (“off time”) of any available therapy for Parkinson’s disease. Levodopa gel correspondingly increased the number of high-quality hours (“on time”).

In a reaffirmation of the “placebo effect” and the benefits of additional clinical oversight that study participants receive, those who received medication in pill form also showed significant improvement, although not to the magnitude of those who received the gel infusion. At the end of the three-month trial, patients who had received the gel placebo had the option of receiving the real medication through the implanted tube.

Janis, now 67, was 51 and working in product development at Procter & Gamble when she first developed symptoms. While drinking coffee at her office, she noticed that her arm would move in a jerky, ratcheting manner as she set the cup down. “Then all of a sudden my pinkie finger started a little tremor,” she recalled. “I went to my family doctor and he suspected it was a brain tumor.”

Janis was referred to a neurosurgeon, who examined her MRI and assured her that she did not have a brain tumor. Suspecting that she might have Parkinson’s disease, the surgeon referred her to a neurologist, who made the diagnosis. “I started to cry,” Janis recalled. “I said, ‘I don’t want it to be Parkinson’s’ — as if I had a choice. The neurologist said — and this was 16 years ago — if you’re ever going to have Parkinson’s, this is the time to have it, because we’re doing a lot of research.”

Janis was able to tolerate her illness for the first few years. But at age 55 she was forced to leave her job because of fatigue and medication side-effects. Seven years after her diagnosis, she became overwhelmed by pain in her left arm and shoulder. “It was so bad that I asked my neurologist whether the arm could be amputated. And I meant it,” she said. “I used to lie on the living room floor and cry.”

Although Parkinson’s disease is most frequently associated with tremor, involuntary movements (dyskinesias), stiffness and slowness, Dr. Espay said that pain is also a primary symptom, particularly among younger-onset patients. “It also can become common as a manifestation of non-motor fluctuations in patients with more advanced Parkinson’s disease.”

Don Yelton, Janis’s husband and devoted caregiver, took early retirement when he was 60 in order to care for her. The disease is not hers alone, he said. “We have Parkinson’s, because what affects her affects me.”

Finally, Janis and Don got a lucky break. Janis’s neurologist, Brian Maddux, MD, PhD, had heard about the new clinical trial and, although he was unaffiliated with UC Health, he referred her to Dr. Espay, who immediately recognized her as a candidate for the study. By this time Janis was taking medications every hour and a half.

Because the study was randomized and double-blinded, Janis did not know whether the surgically implanted tube held the medications or a placebo. But after walking down the hospital hallway a few times after her surgery, she had no doubt that the medication she was receiving was “the real thing.” She turned to Dr. Espay and asked the unthinkable.

“I said, ‘Dr. Espay, boy, do I feel good. I don’t have any pain. Do you think it’s gone? And he said, ‘I think it is.’ I cried. I said you don’t understand. I’ve had pain for 13 years. Then I saw another doctor crying and a nurse crying. Then it became a cry-a-thon.”

Janis’s response to “the pump” was among the most dramatic in the study. She reduced her daily pill intake from 32 to 3 and was once again able to exercise, ride a bike, work in her garden and drive. Don was able to return to work part-time.

“This isn’t a cure, and I still have some problems, but it’s the next best thing,” Janis said. “It’s an effective treatment option. My husband and I feel very blessed.”

Although most patients wear the pump like a pager at the waist, Janis has cleverly hidden hers in the pocket of a brassiere designed for large-breasted women. “I feel like I don’t even have the pump anymore,” she says. “I always complained that the pump was too big and too heavy. But I’ll tell you what: If it was so heavy that I had to push it around in a wheelbarrow in front of me, I’d take it. That’s how good it is. It gave us our lives back.”

— Cindy Starr

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