The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to demonstrate the safety, tolerability, efficacy and
pharmacokinetics of aplindore in patients with early stage Parkinson's Disease (PD) who are
not currently taking any dopamine agonists or who are able to wash off dopamine agonists for
14 days prior to baseline. Efficacy will be assessed using the UPDRS questionnaire including
part 3 of the UPDRS (Motor). their level of sleepiness on a standardized rating scale
(Epworth Sleepiness Scale) and their level of nausea daily.
Safety endpoints will include adverse events (AEs), clinical laboratory data, vital signs
(blood pressure, orthostatic blood pressure and heart rate), ECGs, physical examinations and
self rated scales.