A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease
Status:
Completed
Trial end date:
2014-11-18
Target enrollment:
Participant gender:
Summary
This is a double blind, fixed dose, parallel group study to characterize the dose response of
ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's
disease. The primary endpoint of this study, mean change from baseline in total awake time
spent "off' is the same endpoint as used in the ropinirole PR pivotal study for advanced
Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg)
with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total
awake time spent "off" compared with placebo. The dose of Ldopa will remain stable through
the study, unless the subject experiences tolerability issues that require an L-dopa dose
reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to
approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid
confounding the efficacy data. Clinical review of the primary and secondary endpoints will be
performed in order to establish the lowest maximally effective therapeutic dose.