Full Text View
Tabular View
No Study Results Posted
Related Studies
Investigational Parkinson's Disease In Patients Not Well Controlled On L-Dopa
This study has been completed.
First Received: September 26, 2006   Last Updated: May 15, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00381472
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Drug: Ropinirole
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

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: Levodopa Ropinirole hydrochloride Ropinirole
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 393
Study Start Date: June 2003
  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381472

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294-2041
United States, California
GSK Investigational Site
Northridge, California, United States, 91325
GSK Investigational Site
San Francisco, California, United States, 94109
United States, Colorado
GSK Investigational Site
Englewood, Colorado, United States, 80110
United States, Florida
GSK Investigational Site
Tampa, Florida, United States, 33606
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
Panama City, Florida, United States, 32405
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Augusta, Georgia, United States, 30912
GSK Investigational Site
Atlanta, Georgia, United States, 30329
United States, Illinois
GSK Investigational Site
Glenview, Illinois, United States, 60025
United States, Kansas
GSK Investigational Site
Kansas City, Kansas, United States, 66160
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
GSK Investigational Site
Southfield, Michigan, United States, 48034
GSK Investigational Site
Traverse City, Michigan, United States, 49684
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New York
GSK Investigational Site
Albany, New York, United States, 12205
GSK Investigational Site
New York, New York, United States, 10029-6574
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27705
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
United States, Pennsylvania
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
GSK Investigational Site
Wichita Falls, Texas, United States, 76301
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53233
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2020
GSK Investigational Site
Roeselare, Belgium, 8800
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Edegem, Belgium, 2650
GSK Investigational Site
Hasselt, Belgium, 3500
Czech Republic
GSK Investigational Site
Prague, Czech Republic, 100 34
GSK Investigational Site
Ostrava, Czech Republic, 703 52
GSK Investigational Site
Brno, Czech Republic, 656 91
GSK Investigational Site
Plzen, Czech Republic, 30460
GSK Investigational Site
Ostrava 10, Czech Republic, 710 00
GSK Investigational Site
Pardubice, Czech Republic, 535 03
GSK Investigational Site
Prague, Czech Republic, 120 00
France
GSK Investigational Site
Lille cedex, France, 59037
GSK Investigational Site
Paris Cedex 13, France, 75651
Germany, Niedersachsen
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Germany, Nordrhein-Westfalen
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Germany, Sachsen
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Hungary
GSK Investigational Site
Vasvari Pal street 2, H=9023 Gyor, Hungary
GSK Investigational Site
Budapest, Hungary, 1083
GSK Investigational Site
Pécs, Hungary, 7623
GSK Investigational Site
Miskolc, Hungary, 3529
GSK Investigational Site
Budapest, Hungary, 1096
GSK Investigational Site
Budapest, Hungary, 1145
GSK Investigational Site
Miskolc, Hungary, 3526
GSK Investigational Site
Budapest, Hungary, 1135
GSK Investigational Site
Budapest, Hungary, 1204
Italy, Abruzzo
GSK Investigational Site
Pescara, Abruzzo, Italy, 65100
Italy, Molise
GSK Investigational Site
Pozzilli (IS), Molise, Italy, 86077
Italy, Piemonte
GSK Investigational Site
Torino, Piemonte, Italy, 10100
Italy, Toscana
GSK Investigational Site
Lido Di Camaiore (LU), Toscana, Italy, 55043
GSK Investigational Site
Grosseto, Toscana, Italy, 58100
Italy, Veneto
GSK Investigational Site
Vicenza, Veneto, Italy, 36057
Poland
GSK Investigational Site
Lublin, Poland, 20-718
GSK Investigational Site
Torun, Poland, 87-100
GSK Investigational Site
Warszawa, Poland, 01-337
GSK Investigational Site
Leszno, Poland, 64-100
GSK Investigational Site
Warsaw, Poland, 02-097
GSK Investigational Site
Lublin, Poland, 20-954
GSK Investigational Site
Krakow, Poland, 31-530
GSK Investigational Site
Bialystok, Poland, 15-276
GSK Investigational Site
Ciborz, Poland, 66-212
GSK Investigational Site
Gdansk, Poland, 80-308
GSK Investigational Site
Gdansk, Poland, 80-211
GSK Investigational Site
Katowice, Poland, 40-752
Spain
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Madrid, Spain, 28660
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: 101468/169
Study First Received: September 26, 2006
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00381472     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Parkinson's Disease
Adjunctive Therapy with L-dopa
Dyskinesia

Additional relevant MeSH terms:
Neurotransmitter Agents
Levodopa
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 27, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services