Motor Symptoms Treatment Study for Patients with Parkinson's
The purpose of this research study is to learn if APOKYN given by continuous subcutaneous infusion can rapidly and reliably improve your motor symptoms. This study will involve about 60 subjects at approximately 15 centers in the United States and all subjects will receive APOKYN. Up to about 6 subjects are anticipated to be enrolled at Rush University Medical Center. Study participation last about 56 weeks including 16 study visits and the option to participate in a 6 month extension study.
In order to participate you must meet the following criteria:
- Be male or female 30 to 80 years of age.
- Have a diagnosis of idiopathic Parkinson’s disease.
- Are not currently taking APOKYN and, if previously prescribed APOKYN, did not discontinue therapy due to intolerable side effects/safety reasons.
- Are on levodopa (L-dopa) therapy at a steady maintenance dose, representing an optimal treatment regimen in the opinion of the investigator, for at least 4 weeks before study participation AND at least one dopamine agonist.
- Be able to adequately differentiate between and describe variations in “on” and “off” states in the opinion of the Investigator and be able to maintain a motor diary.
- Experience “off” periods averaging ≥2.5 hours per day.
You will be excluded from the study if any of the following criteria apply to you:
- Have had changes in your L-dopa dosing regimen 4 weeks before the screening visit.
- Are female and are pregnant or lactating.
- Have participated in any other clinical trial within 14 days of the screening visit.
This is a partial list of inclusion and exclusion criteria.