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 - Full Text View

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

This study is ongoing, but not recruiting participants.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00650104

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Ropinirole XL (formerly CR)	Phase III

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

ChemIDplus related topics:

Ropinirole Ropinirole hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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).

Estimated Enrollment:	83
Study Start Date:	May 2002
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650104

Locations


United States, Arizona
	GSK Clinical Trials Call Center
	Scottsdale, Arizona, United States, 85259

United States, Arkansas
	GSK Clinical Trials Call Center
	Little Rock, Arkansas, United States, 72205

United States, California
	GSK Clinical Trials Call Center
	Los Angeles, California, United States, 90033
	GSK Clinical Trials Call Center
	Oxnard, California, United States, 93030

United States, Florida
	GSK Clinical Trials Call Center
	Miami, Florida, United States, 33136
	GSK Clinical Trials Call Center
	Tampa, Florida, United States, 33606

United States, Georgia
	GSK Clinical Trials Call Center
	Augusta, Georgia, United States, 30912

United States, Kansas
	GSK Clinical Trials Call Center
	Kansas City, Kansas, United States, 66160

United States, New Jersey
	GSK Clinical Trials Call Center
	Edison, New Jersey, United States, 08818

United States, Pennsylvania
	GSK Clinical Trials Call Center
	Upland, Pennsylvania, United States, 19013

United States, Texas
	GSK Clinical Trials Call Center
	Houston, Texas, United States, 77030

Belgium
	GSK Clinical Trials Call Centre
	Hasselt, Belgium, 3500
	GSK Clinical Trials Call Centre
	Roeselare, Belgium, B-8800

France
	GSK Clinical Trials Call Centre
	Toulouse, France, 31059

Netherlands
	GSK Clinical Trials Call Centre
	Heerlen, Netherlands, 6419 PC

Norway
	GSK Clinical Trials Call Centre
	Fredrikstad, Norway, N-1603

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	101468/196
First Received:	March 27, 2008
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00650104
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency

Keywords provided by GlaxoSmithKline:

Parkinson's disease

open-label

long term safety; REQUIP

ropinirole IR

ropinirole CR

ropinirole XL

safety

efficacy

Study placed in the following topic categories:

Ropinirole

Dopamine

Ganglion Cysts

Movement Disorders

Parkinson Disease

Basal Ganglia Diseases

Central Nervous System Diseases

Parkinsonian Disorders

Neurodegenerative Diseases

Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Antiparkinson Agents

Dopamine Agents

Dopamine Agonists

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008