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Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ropinirole
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Dyskinesia, Adjunctive Therapy with L-dopa

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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

Full Information

First Posted
September 26, 2006
Last Updated
March 21, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00381472
Brief Title
Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Dyskinesia, Adjunctive Therapy with L-dopa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
393 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ropinirole
Primary Outcome Measure Information:
Title
Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
Secondary Outcome Measure Information:
Title
Mean change from baseline in:
Title
amount and percent of awake time spent "on"
Title
percent awake time spent "off"
Title
Unified Parkinson's Disease Rating Scale (UPDRS) total motor score
Title
UPDRS Activities of Daily Living score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2041
Country
United States
Facility Name
GSK Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
GSK Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
GSK Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
GSK Investigational Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
GSK Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
GSK Investigational Site
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
GSK Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
GSK Investigational Site
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
GSK Investigational Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
GSK Investigational Site
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
GSK Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
GSK Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
GSK Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614-5809
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
GSK Investigational Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
GSK Investigational Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GSK Investigational Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava 10
ZIP/Postal Code
710 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
703 52
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
535 03
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Plzen
ZIP/Postal Code
30460
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Prague
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Prague
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Prague
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Aix en Provence
ZIP/Postal Code
13090
Country
France
Facility Name
GSK Investigational Site
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
GSK Investigational Site
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
GSK Investigational Site
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
GSK Investigational Site
City
Vasvari Pal street 2, H=9023 Gyor
Country
Hungary
Facility Name
GSK Investigational Site
City
Pozzilli (IS)
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
GSK Investigational Site
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10100
Country
Italy
Facility Name
GSK Investigational Site
City
Grosseto
State/Province
Toscana
ZIP/Postal Code
58100
Country
Italy
Facility Name
GSK Investigational Site
City
Lido Di Camaiore (LU)
State/Province
Toscana
ZIP/Postal Code
55043
Country
Italy
Facility Name
GSK Investigational Site
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36057
Country
Italy
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
GSK Investigational Site
City
Ciborz
ZIP/Postal Code
66-212
Country
Poland
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
80-308
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
GSK Investigational Site
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
GSK Investigational Site
City
Szwajcarska 3
ZIP/Postal Code
61-285 Poznań Ul.
Country
Poland
Facility Name
GSK Investigational Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
GSK Investigational Site
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
01-337
Country
Poland
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
21687750
Citation
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.
Results Reference
background
PubMed Identifier
21699627
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
17404192
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/169
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/169
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/169
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/169
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/169
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/169
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101468/169
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

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