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REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study

GlaxoSmithKline · 2007
ClinicalTrials.gov · Datasets · License: Public Domain · 2007
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parkinson-diseaseparkinson-s-disease
Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006. ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP at \>10mg/day is limited. For this reason, this study was designed as a multicenter open-label uncontrolled study. This study will evaluate the long-term efficacy (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn \& Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.
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