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

Tracking Information

First Received Date ^ICMJE

September 26, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00381472 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: Ropinirole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

393

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain

Administrative Information

NCT ID ^ICMJE

NCT00381472

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

101468/169

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP