( e blood plasmafluctuations over 24 hou...)Once Daily, Extended-Release Ropinirole Improves Parkinson's,Symptoms in Patients not Optimally Controlled With Levodopa,Health

e blood plasma fluctuations over 24 hours. In the EASE- PD Adjunct Study, REQUIP XL 24-Hour has been shown to be effective in treating both motor and non-motor symptoms of Parkinson's disease as an addition to L- dopa. GlaxoSmithKline sponsored this study as part of the clinical development program for the investigational 24-hour extended-release tablet dosage formulation of REQUIP. REQUIP XL 24-Hour is the proposed brand name for a once-a-day formulation of ropinirole for treating Parkinson's disease using SkyePharma Plc's proprietary GeoMatrix technology.

About the Study

The EASE-PD Adjunct study was a multi-center, double-blind, placebo- controlled study, conducted in patients with idiopathic Parkinson's disease not adequately controlled with L-dopa. Subjects were randomized (1:1) to receive REQUIP XL 24-Hour (n=202) or placebo (n=191) in addition to L-dopa, once daily for 24 weeks. The primary endpoint was mean change from baseline in awake time spent 'off' (measured via patient diaries). REQUIP XL 24-Hour decreased patients' awake time spent 'off' by an average of 2.1 hours per day, while placebo decreased awake time spent 'off' by 0.3 hours per day.

The study also included a wide variety of motor and non-motor secondary endpoints, including 'on' time which refers to the time during which medication is working and providing benefit, and 'on' time without troublesome dyskinesia which refers to 'on' time without involuntary movements interfering with function or causing discomfort, a common problem in Parkinson's disease. REQUIP XL 24-Hour significantly increased both 'on' time and 'on' time without troublesome dyskinesia by 1.6 hours per day (a greater than 12 percent increase) and reduced the percentage of 'off' time by more than 12 percent compared to baseline. REQUIP XL 24-Hour also improved sleep problems associated with Parkinson's disease, as measured by the Parkinson's Disease Sleep Scale total score.

There were other motor and
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