Investigational Parkinson's Disease In Patients Not Well Controlled On L-Dopa

Condition(s) targeted: Parkinson's Disease

Intervention: Ropinirole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).

Secondary outcome:

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

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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.

- Dementia

- Use of dopamine agonists within 4 weeks of screening visit.

- Participation in other investigational drug studies.

GSK Clinical Trials Call Center, Birmingham, Alabama 35233-0017, United States

GSK Clinical Trials Call Center, Northridge, California 91325, United States

GSK Clinical Trials Call Center, Fountain Valley, California 92708, United States

GSK Clinical Trials Call Center, San Francisco, California 94109, United States

GSK Clinical Trials Call Center, Englewood, Colorado 80110, United States

GSK Clinical Trials Call Center, Tampa, Florida 33606, United States

GSK Clinical Trials Call Center, Boca Raton, Florida 33486, United States

GSK Clinical Trials Call Center, Panama City, Florida 32405, United States

GSK Clinical Trials Call Center, St. Petersburg, Florida 33701, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30329, United States

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GSK Clinical Trials Call Center, Southfield, Michigan 48034, United States

GSK Clinical Trials Call Center, Traverse City, Michigan 49684, United States

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GSK Clinical Trials Call Center, Raleigh, North Carolina 27607, United States

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GSK Clinical Trials Call Center, Toledo, Ohio 43614, United States

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Starting date: July 2003
Last updated: September 26, 2006