Conditions: Parkinson Disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 295
Healthy volunteers: no

Brief summary:
This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.

Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.

Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.

Detailed description:

Arms:
arm 1: Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg

Interventions: intervention 1: Requip PR
Intervention descriptions: intervention 1: Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.

Protocol document: