Objective/Rationale:
Parkinson’s disease (PD) often results in slower than normal emptying of food and medications from the stomach. This delayed gastric emptying is estimated to affect 50-90 percent of PD patients. Levodopa, the gold standard PD medication, is absorbed when it reaches the upper intestine. If gastric emptying is delayed, levodopa may be erratically absorbed, resulting in slower relief of symptoms and "on-off" fluctuations. GSK962040 is a medication that, in research studies, has been shown to increase the speed at which the stomach empties. This project will study the effects of GSK962040 in people with Parkinson’s and delayed gastric emptying.
Project Description:
Up to 70 people with Parkinson’s and confirmed delayed gastric emptying will be randomly assigned to receive either GSK962040 or an inactive placebo tablet. Patients will take the tablets once daily for a total of eight days. Neither the participants nor the study doctors will know which tablet the patient has received until the end of the project. Participants will be assessed regularly before, during and after receiving the study medication. Researchers will measure participants’ levodopa levels in the blood, changes in gastric emptying rates and motor (movement) symptoms to determine if GSK962040 can increase the speed of gastric emptying, improve levodopa absorption, improve the effect of levodopa on the motor (movement) symptoms of Parkinson’s and improve the gastrointestinal symptoms that can result from delayed gastric emptying.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
If this medication is shown to increase the speed of gastric emptying, and as a consequence increase rates of levodopa absorption, it has the potential to be an effective treatment to improve gastrointestinal symptoms and enhance and extend the effects of levodopa in people with Parkinson’s.
Anticipated Outcome:
By increasing the rate of gastric emptying in people with Parkinson’s, it is anticipated that GSK962040 will increase rates of absorption of levodopa. Quicker absorption of levodopa will shorten the period of time between taking the medication and seeing improvement in symptoms. The period of time for which levodopa improves movement (“on” time) is expected to increase when GSK962040 is also taken. Additionally, the symptoms that can result from delayed gastric emptying (nausea, feeling bloated or full quickly after meals) are expected to improve in people taking GSK962040.
Final Outcome
In total 19 patients received the inactive placebo and 37 received 50mg of the study medicine GSK 962040, also called Camicinal. Those patients who took Camicinal showed an improvement in “on” time where levodopa improved motor symptoms. Additionally, symptoms that can result from delayed gastric emptying such as constipation were slightly improved among some taking Camicinal – though a longer study is needed to confirm this. The study treatment was generally well tolerated throughout the study.
October 2014