Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa
The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa|
- Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
- Mean change from baseline in:
- amount and percent of awake time spent "on"
- percent awake time spent "off"
- Unified Parkinson's Disease Rating Scale (UPDRS) total motor score
- UPDRS Activities of Daily Living score
|Study Start Date:||June 2003|
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|