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

Sponsor:	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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, 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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

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

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Locations

United States, Arizona
GSK Investigational Site
Scottsdale, Arizona, United States, 85259
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Oxnard, California, United States, 93030
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Fountain Valley, California, United States, 92708
United States, Connecticut
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Panama City, Florida, United States, 32405
GSK Investigational Site
Tampa, Florida, United States, 33606
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Kansas
GSK Investigational Site
Kansas City, Kansas, United States, 66160
United States, Michigan
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
GSK Investigational Site
Traverse City, Michigan, United States, 49684
United States, New Jersey
GSK Investigational Site
Edison, New Jersey, United States, 08818
United States, Ohio
GSK Investigational Site
Dayton, Ohio, United States, 45409
United States, Pennsylvania
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
GSK Investigational Site
Wynnewood, Pennsylvania, United States, 19096
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
Belgium
GSK Investigational Site
Hasselt, Belgium, 3500
GSK Investigational Site
Roeselare, Belgium, 8800
France
GSK Investigational Site
Toulouse Cedex 9, France, 31059
Netherlands
GSK Investigational Site
HEERLEN, Netherlands, 6419 PC
Norway
GSK Investigational Site
Forde, Norway

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101468/196
Study First Received:	March 27, 2008
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00650104 History of Changes
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

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents
Dopamine Agonists

Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009