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Ropinirole PR/XR vs IR in Advanced Parkinson's Disease

NCT00823836Phase 3

Key facts

Status: Completed
Start: Mar 2009
Primary completion: Dec 2010
Countries: 1
Sponsor: GSK
Modality: Small Molecules

Drugs: ropinirole
Conditions: Parkinson's disease (PD)

Overview

Phase 3, randomised, double-blind trial of ropinirole in Parkinson's disease (PD) (2 arms), sponsored by GSK. Primary endpoint: Japanese Unified Parkinson's Disease Rating Scale Part III Total Score at 24 weeks. Started Mar 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

ropinirole PR-PR group
Ropinirole PR/XR throughout the study.
ropinirole IR-PR group
Ropinirole IR for first 24 weeks, then switched to Ropinirole PR/XR.

Who it enrols

Patients with advanced Parkinson's disease (Hoehn & Yahr Stages II-IV) on a stable dose of L-dopa with wearing-off phenomena. Excludes patients with severe dementia, major psychosis, or recent dopamine agonist use.

Endpoints

Primary

Japanese Unified Parkinson's Disease Rating Scale Part III Total Score24 weeks

Secondary

Percentage of Responders on the Japanese UPDRS Part III Total Score54 weeks
Japanese Unified Parkinson's Disease Rating Scale Part I Total Score54 weeks
Japanese Unified Parkinson's Disease Rating Scale Part II (at 'On') Total Score54 weeks
Japanese Unified Parkinson's Disease Rating Scale Part II (at 'Off') Total Score54 weeks
Japanese Unified Parkinson's Disease Rating Scale Part IV Total Score54 weeks
Clinical Global Impression-Improvement54 weeks
Awake Time Spent 'Off'54 weeks
Awake Time Spent 'On'24 weeks

Results

Primary endpoints met

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