Conditions: Parkinson Disease
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 186
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: ropinirole 2, 4, 8, 12, or 24 mg/day arm 2: placebo comparator 2, 4, 8, 12, or 24 mg/day

Interventions: intervention 1: ropinirole monotherapy intervention 2: placebo monotherapy
Intervention descriptions: intervention 1: ropinirole as monotherapy in Parkinson's disease intervention 2: placebo as monotherapy in Parkinson's disease

Protocol document: