This study is investigating the metabolism and safety of opicapone in patients with Parkinson’s disease who are already taking levodopa/carbidopa. This study is recruiting in Glendale and Long Beach, California as well as Farmington Hills, Michigan.
The details
Opicapone is a new COMT inhibitor. This type of treatment prolongs the effects of levodopa by preventing the breakdown of dopamine. This can help decrease the duration of “off” periods, when levodopa does not help motor symptoms. Opicapone is thought to have fewer side effects and a simpler dose regimen compared to other COMT inhibitors.
This study is investigating the metabolism and safety of opicapone in patients with Parkinson’s disease who are already taking levodopa/carbidopa (Sinemet). The main outcomes to be measured include the metabolism and safety of this new drug.
Who are they looking for?
This study is recruiting 16 patients who have had clear improvement in Parkinson’s symptoms for at least 3 years with levodopa treatment. Patients must be on stable doses of medications, including levodopa/carbidopa. Patients must have Hoehn and Yahr stage 4 disease or less when in the OFF state (when symptoms have returned). Patients must agree to use contraception throughout the study and follow-up periods.
Patients who are breastfeeding or pregnant cannot participate. Patients who drink more than 2 alcoholic beverages daily cannot participate. Patients with motor fluctuations during the day or severe dyskinesia (involuntary movements) cannot participate. Patients who were treated with opicapone before or who are allergic to it or other similar medications cannot participate. Patients with AIDS, HIV, hepatitis A, or hepatitis B cannot participate.
How will it work
Patients will take opicapone once daily by mouth for 14 days. Levodopa/carbidopa will also be given on days 1, 2, and 15 of the study.
The absorption and metabolism of opicapone, including blood levels, will be measured for up to 19 days. Blood levels of levodopa will be measured for up to 15 days. Side effects associated with opicapone are also determined for up to 19 days.
