Parkinson Disease Clinical Trial
Official title:
Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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