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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




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