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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00381472
Collaborator
(none)
393
Enrollment
76
Locations
18
Duration (Months)
5.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2003
Actual Study Completion Date :
Dec 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward). []

Secondary Outcome Measures

  1. Mean change from baseline in: []

  2. amount and percent of awake time spent "on" []

  3. percent awake time spent "off" []

  4. Unified Parkinson's Disease Rating Scale (UPDRS) total motor score []

  5. UPDRS Activities of Daily Living score []

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 GSK Investigational Site Birmingham Alabama United States 35294-2041
2 GSK Investigational Site Northridge California United States 91325
3 GSK Investigational Site San Francisco California United States 94109
4 GSK Investigational Site Englewood Colorado United States 80110
5 GSK Investigational Site Boca Raton Florida United States 33486
6 GSK Investigational Site Panama City Florida United States 32405
7 GSK Investigational Site St. Petersburg Florida United States 33701
8 GSK Investigational Site Tampa Florida United States 33606
9 GSK Investigational Site Atlanta Georgia United States 30329
10 GSK Investigational Site Atlanta Georgia United States 30342
11 GSK Investigational Site Augusta Georgia United States 30912
12 GSK Investigational Site Glenview Illinois United States 60025
13 GSK Investigational Site Kansas City Kansas United States 66160
14 GSK Investigational Site Boston Massachusetts United States 02215
15 GSK Investigational Site Bingham Farms Michigan United States 48025
16 GSK Investigational Site Southfield Michigan United States 48034
17 GSK Investigational Site Traverse City Michigan United States 49684
18 GSK Investigational Site Las Vegas Nevada United States 89102
19 GSK Investigational Site Albany New York United States 12205
20 GSK Investigational Site New York New York United States 10029-6574
21 GSK Investigational Site Charlotte North Carolina United States 28209
22 GSK Investigational Site Durham North Carolina United States 27705
23 GSK Investigational Site Raleigh North Carolina United States 27607
24 GSK Investigational Site Toledo Ohio United States 43614-5809
25 GSK Investigational Site Philadelphia Pennsylvania United States 19107
26 GSK Investigational Site Upland Pennsylvania United States 19013
27 GSK Investigational Site Wichita Falls Texas United States 76301
28 GSK Investigational Site Milwaukee Wisconsin United States 53233
29 GSK Investigational Site Antwerpen Belgium 2020
30 GSK Investigational Site Edegem Belgium 2650
31 GSK Investigational Site Hasselt Belgium 3500
32 GSK Investigational Site Leuven Belgium 3000
33 GSK Investigational Site Roeselare Belgium 8800
34 GSK Investigational Site Brno Czech Republic 656 91
35 GSK Investigational Site Hradec Kralove Czech Republic 500 05
36 GSK Investigational Site Ostrava 10 Czech Republic 710 00
37 GSK Investigational Site Ostrava Czech Republic 703 52
38 GSK Investigational Site Pardubice Czech Republic 535 03
39 GSK Investigational Site Plzen Czech Republic 30460
40 GSK Investigational Site Prague Czech Republic 100 34
41 GSK Investigational Site Prague Czech Republic 120 00
42 GSK Investigational Site Prague Czech Republic 128 08
43 GSK Investigational Site Aix en Provence France 13090
44 GSK Investigational Site Lille cedex France 59037
45 GSK Investigational Site Paris Cedex 13 France 75651
46 GSK Investigational Site Poitiers Cedex France 86021
47 GSK Investigational Site Bochum Nordrhein-Westfalen Germany 44791
48 GSK Investigational Site Leipzig Sachsen Germany 04103
49 GSK Investigational Site Budapest Hungary 1083
50 GSK Investigational Site Budapest Hungary 1096
51 GSK Investigational Site Budapest Hungary 1135
52 GSK Investigational Site Budapest Hungary 1145
53 GSK Investigational Site Budapest Hungary 1204
54 GSK Investigational Site Miskolc Hungary 3526
55 GSK Investigational Site Miskolc Hungary 3529
56 GSK Investigational Site Pécs Hungary 7623
57 GSK Investigational Site Vasvari Pal street 2, H=9023 Gyor Hungary
58 GSK Investigational Site Pozzilli (IS) Molise Italy 86077
59 GSK Investigational Site Torino Piemonte Italy 10100
60 GSK Investigational Site Grosseto Toscana Italy 58100
61 GSK Investigational Site Lido Di Camaiore (LU) Toscana Italy 55043
62 GSK Investigational Site Vicenza Veneto Italy 36057
63 GSK Investigational Site Bialystok Poland 15-276
64 GSK Investigational Site Ciborz Poland 66-212
65 GSK Investigational Site Gdansk Poland 80-211
66 GSK Investigational Site Gdansk Poland 80-308
67 GSK Investigational Site Katowice Poland 40-752
68 GSK Investigational Site Krakow Poland 31-530
69 GSK Investigational Site Leszno Poland 64-100
70 GSK Investigational Site Lublin Poland 20-718
71 GSK Investigational Site Lublin Poland 20-954
72 GSK Investigational Site Szwajcarska 3 Poland 61-285 Poznań Ul.
73 GSK Investigational Site Torun Poland 87-100
74 GSK Investigational Site Warsaw Poland 02-097
75 GSK Investigational Site Warszawa Poland 01-337
76 GSK Investigational Site Barcelona Spain 08025

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00381472
Other Study ID Numbers:
  • 101468/169
First Posted:
Sep 27, 2006
Last Update Posted:
Mar 23, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Parkinson's Disease
Dyskinesia
Adjunctive Therapy with L-dopa
Additional relevant MeSH terms:
Parkinson Disease
Ropinirole

Study Results

No Results Posted as of Mar 23, 2017