Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa
NCT ID: NCT00381472
Last Updated: 2017-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
393 participants
INTERVENTIONAL
2003-06-30
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Ropinirole
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Northridge, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Englewood, Colorado, United States
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Boca Raton, Florida, United States
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Panama City, Florida, United States
GSK Investigational Site
St. Petersburg, Florida, United States
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Tampa, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Glenview, Illinois, United States
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Kansas City, Kansas, United States
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Boston, Massachusetts, United States
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Bingham Farms, Michigan, United States
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Southfield, Michigan, United States
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Traverse City, Michigan, United States
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Las Vegas, Nevada, United States
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Albany, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Toledo, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Wichita Falls, Texas, United States
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Milwaukee, Wisconsin, United States
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Antwerp, , Belgium
GSK Investigational Site
Edegem, , Belgium
GSK Investigational Site
Hasselt, , Belgium
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Leuven, , Belgium
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Roeselare, , Belgium
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Brno, , Czechia
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Hradec Králové, , Czechia
GSK Investigational Site
Ostrava, , Czechia
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Ostrava, , Czechia
GSK Investigational Site
Pardubice, , Czechia
GSK Investigational Site
Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aix-en-Provence, , France
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Lille, , France
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Paris, , France
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Poitiers, , France
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Bochum, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Budapest, , Hungary
GSK Investigational Site
Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Miskolc, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
GSK Investigational Site
Vasvari Pal Street 2, H=9023 Gyor, , Hungary
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Pozzilli (IS), Molise, Italy
GSK Investigational Site
Turin, Piedmont, Italy
GSK Investigational Site
Grosseto, Tuscany, Italy
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Lido Di Camaiore (LU), Tuscany, Italy
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Vicenza, Veneto, Italy
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Bialystok, , Poland
GSK Investigational Site
Cibórz, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Leszno, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Szwajcarska 3, , Poland
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Torun, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Barcelona, , Spain
Countries
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References
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B P Hersh, S A Factor, L Giorgi Ropinirole 24-hour prolonged release improves motor function and activities of daily living as an adjunct to L-dopa in Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2: 13/S2-P2202
F Stocchi, B Hersh, N Earl, B Scott Safety and tolerability of ropinirole 24-hour prolonged release in patients with early and advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S572/P894.
F Stocchi, M A Stacy, L Giorgi, N L Earl Safety and tolerability of ropinirole 24-hour prolonged release as adjuctive therapy to L-dopa in patients with Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2-13/a2P2201
Reichmann H, Cooper J, Rolfe K, Martinez-Martin P. Sleep Duration and "on" Time during Different Periods of the Day and Night in Patients with Advanced Parkinson's Disease Receiving Adjunctive Ropinirole Prolonged Release. Parkinsons Dis. 2011;2011:354760. doi: 10.4061/2011/354760. Epub 2011 May 11.
Ray Chaudhuri K, Martinez-Martin P, Rolfe KA, Cooper J, Rockett CB, Giorgi L, Ondo WG. Improvements in nocturnal symptoms with ropinirole prolonged release in patients with advanced Parkinson's disease. Eur J Neurol. 2012 Jan;19(1):105-13. doi: 10.1111/j.1468-1331.2011.03442.x. Epub 2011 Jun 23.
K Sethi, N Earl, R Hauser Ropinirole 24-hour prolonged release improves disease-specific and global symptoms when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S570/P887
M A Stacy, K D Sethi, N L Earl Ropinirole 24-hour prolonged release improves sleep but does not increase daytime sleepiness when used as adjunctive therapy in patients with Parkinson's Disease not optimally controlled by L-dopa. Movement Disorders, November 2006 S15/9.21:1543-1559
M Stacy, R Pahwa, N Earl Ropinirole 24-hour prolonged release reduces "off" time and reduces the need for L-dopa when used as adjunctive therapy in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S596/P972
R A Hauser, M A Stacy, B P Hersh Ropinirole 24 hour prolonged release reduces off time and improves depression when used as adjunctive therapy in patients with Parkinson's disease not optimally controlled with L-dopa Movement Disorders S15-21-P8
R Pahwa, F Stocchi, M A Stacy Ropinirole 24-hour prolonged release is effective in sparing L-dopa dose and improving symptoms as adjuctive therapy in Parkinson's Disease. Eur J Neurol, September 2005/Suppl 2:s2-P2203
R Pahwa, M Stacy, E Elmer, S Isaacson Ropinirole 24-hour prolonged release provides efficacy as early as Week 2 when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S595/P968.
Pahwa R, Stacy MA, Factor SA, Lyons KE, Stocchi F, Hersh BP, Elmer LW, Truong DD, Earl NL; EASE-PD Adjunct Study Investigators. Ropinirole 24-hour prolonged release: randomized, controlled study in advanced Parkinson disease. Neurology. 2007 Apr 3;68(14):1108-15. doi: 10.1212/01.wnl.0000258660.74391.c1.
R Pahwa, S Factor, L Elmer Ropinirole 24 hour prolonged release reduces awake time spent "off" in patients with Parkinson's disease not optimally controlled with L-dopa. Neurology, April 2006. 66 (Suppl 2): A292. P05.135
R Pahwa, SA Factor, L Elmer Ropinirole 24 hour prolonged release reduces "off" time in patients with Parkinson's disease not optimally controlled with L-dopa. Eur J Neurol, September 2006/Suppl2, 13/s2:P2154.
Study Documents
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Document Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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101468/169
Identifier Type: -
Identifier Source: org_study_id
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