A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
Status:
Completed
Trial end date:
2014-04-30
Target enrollment:
Participant gender:
Summary
This study is a fixed dose, dose response study to characterize the dose response for
ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and
baseline assessments, subjects will be randomized to one of six final target treatment groups
(placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening
period, an up-titration period, a maintenance period, a down titration period and a follow up
period. This study utilizes change from baseline in the UPDRS motor score as the primary
endpoint, in line with that used in the ropinirole PR monotherapy pivotal study
(SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in
order to establish the lowest maximally effective therapeutic dose.