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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in: | ||
| amount and percent of awake time spent "on" | ||
| percent awake time spent "off" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294-2041 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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. | ||
| Background | 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 | ||
| 21687750 | Background | 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 101468/169 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Unified Parkinson's Disease Rating Scale (UPDRS) total motor score |
| UPDRS Activities of Daily Living score |
| Northridge |
| California |
| 91325 |
| United States |
| GSK Investigational Site | San Francisco | California | 94109 | United States |
| GSK Investigational Site | Englewood | Colorado | 80110 | United States |
| GSK Investigational Site | Boca Raton | Florida | 33486 | United States |
| GSK Investigational Site | Panama City | Florida | 32405 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33701 | United States |
| GSK Investigational Site | Tampa | Florida | 33606 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30329 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Augusta | Georgia | 30912 | United States |
| GSK Investigational Site | Glenview | Illinois | 60025 | United States |
| GSK Investigational Site | Kansas City | Kansas | 66160 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| GSK Investigational Site | Southfield | Michigan | 48034 | United States |
| GSK Investigational Site | Traverse City | Michigan | 49684 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89102 | United States |
| GSK Investigational Site | Albany | New York | 12205 | United States |
| GSK Investigational Site | New York | New York | 10029-6574 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Durham | North Carolina | 27705 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Toledo | Ohio | 43614-5809 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Upland | Pennsylvania | 19013 | United States |
| GSK Investigational Site | Wichita Falls | Texas | 76301 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53233 | United States |
| GSK Investigational Site | Antwerp | 2020 | Belgium |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Hasselt | 3500 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Roeselare | 8800 | Belgium |
| GSK Investigational Site | Brno | 656 91 | Czechia |
| GSK Investigational Site | Hradec Krålové | 500 05 | Czechia |
| GSK Investigational Site | Ostrava | 703 52 | Czechia |
| GSK Investigational Site | Ostrava | 710 00 | Czechia |
| GSK Investigational Site | Pardubice | 535 03 | Czechia |
| GSK Investigational Site | Pilsen | 30460 | Czechia |
| GSK Investigational Site | Prague | 100 34 | Czechia |
| GSK Investigational Site | Prague | 120 00 | Czechia |
| GSK Investigational Site | Prague | 128 08 | Czechia |
| GSK Investigational Site | Aix-en-Provence | 13090 | France |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Paris | 75651 | France |
| GSK Investigational Site | Poitiers | 86021 | France |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Budapest | 1083 | Hungary |
| GSK Investigational Site | Budapest | 1096 | Hungary |
| GSK Investigational Site | Budapest | 1135 | Hungary |
| GSK Investigational Site | Budapest | 1145 | Hungary |
| GSK Investigational Site | Budapest | 1204 | Hungary |
| GSK Investigational Site | Miskolc | 3526 | Hungary |
| GSK Investigational Site | Miskolc | 3529 | Hungary |
| GSK Investigational Site | Pécs | 7623 | Hungary |
| GSK Investigational Site | Vasvari Pal Street 2, H=9023 Gyor | Hungary |
| GSK Investigational Site | Pozzilli (IS) | Molise | 86077 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10100 | Italy |
| GSK Investigational Site | Grosseto | Tuscany | 58100 | Italy |
| GSK Investigational Site | Lido Di Camaiore (LU) | Tuscany | 55043 | Italy |
| GSK Investigational Site | Vicenza | Veneto | 36057 | Italy |
| GSK Investigational Site | Bialystok | 15-276 | Poland |
| GSK Investigational Site | CibĂłrz | 66-212 | Poland |
| GSK Investigational Site | Gdansk | 80-211 | Poland |
| GSK Investigational Site | Gdansk | 80-308 | Poland |
| GSK Investigational Site | Katowice | 40-752 | Poland |
| GSK Investigational Site | Krakow | 31-530 | Poland |
| GSK Investigational Site | Leszno | 64-100 | Poland |
| GSK Investigational Site | Lublin | 20-718 | Poland |
| GSK Investigational Site | Lublin | 20-954 | Poland |
| GSK Investigational Site | Szwajcarska 3 | 61-285 PoznaĆ Ul. | Poland |
| GSK Investigational Site | Torun | 87-100 | Poland |
| GSK Investigational Site | Warsaw | 01-337 | Poland |
| GSK Investigational Site | Warsaw | 02-097 | Poland |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| 21699627 | Background | 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. |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | 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 |
| Background | 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. |
| 17404192 | Background | 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. |
| Background | 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 |
| Background | 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/169 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/169 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/169 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/169 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/169 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/169 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
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