Long-Term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164 - Tabular View

Tracking Information

First Received Date ^ICMJE

March 27, 2008

Last Updated Date

February 19, 2009

Start Date ^ICMJE

May 2002

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability are assessed by monitoring AEs, concomitant medications, orthostatic blood pressure/pulse, ECGs, and physical examinations.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00650104 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy is assessed using Clinical Global Impression (Part 1 and 2; for the first year of the study only) and the Unified Parkinson's Disease Rating Scale (UPDRS) (Part II and III).

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Long-Term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164

Official Title ^ICMJE

101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson''s Disease Who Completed the Previous Ropinirole CR Studies 167 or 164

Brief Summary

The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Drug: Ropinirole XL (formerly CR)

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males or non-pregnant/non-breast feeding females
At least 30 years of age
Diagnosis of idiopathic Parkinson''s disease (Hoehn & Yahr criteria)
Completed either Study 167 or Study 164

Exclusion Criteria:

Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
Dizziness or fainting due to orthostatic hypotension on standing
Significant sleep disorder
Drug abuse or alcoholism

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, France, Netherlands, Norway

Administrative Information

NCT ID ^ICMJE

NCT00650104

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

101468/196

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2009

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