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

GlaxoSmithKline1 site in 1 country393 target enrollmentJune 2003

ConditionsParkinson Disease

DrugsRopinirole

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: GlaxoSmithKline
Enrollment: 393
Locations: 1
Primary Endpoint: Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

December 2004

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Idiopathic Parkinson's disease
•Modified Hoehn and Yahr Scale Stages II - IV
•Stable dose of L-dopa for at least 4 weeks prior to screening.
•Lack of control with L-dopa therapy.
•Women of child-bearing potential must use a clinically accepted form of birth control.

Exclusion Criteria

•Significant and/or uncontrolled medical conditions (excluding Parkinson's disease) within 3 months of screening.
•Any abnormality, at screening, that is considered clinically relevant by the Investigator.
•Use of dopamine agonists within 4 weeks of screening visit.
•Participation in other investigational drug studies.