Last updated: 11/02/2018 23:26:36
Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Ropinirole
Enrollment:
393
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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
Heinz Reichmann, James Cooper, Katie Rolfe, Pablo Martinez-Martin. 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. [Park Dis]. 2011;2011(354760):1-8.
K Ray Chaudhuri, Pablo Martinez-Martin, Katie Rolfe, James Cooper, Carol Rockett, Luigi Giorgi, Bill Ondo. Improvements in nocturnal symptoms with ropinirole prolonged release in patients with advanced Parkinson’s disease . [Eur J Neurol]. 2012;19(1):105-113.
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.
R Pahwa, MA Stacy, SA Factor, KE Lyons, F Stocchi, BP Hersh, LW Elmer, DD Truong, NL Earl, Ropinirole 24 hour prolonged release: Randomised controlled study in advanced Parkinson’s disease. Neurology, 2007. 68: 1108-1115
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.
D Tompson, R Oliver-Willwong. Pharmacokinetic and Pharmacodynamic Comparison of Ropinirole 24-Hour Prolonged-Release and Ropinirole Immediate-Release in Patients with Parkinson’s Disease. Clin Neuropharmacol. 2009;32(3):140-8.
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
June 2003 to December 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30+ years
Accepts healthy volunteers
No
- Idiopathic Parkinson's disease
- Modified Hoehn and Yahr Scale Stages II - IV
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294-2041
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Will Be Recruiting
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Study Complete
Location
GSK Investigational Site
Panama City, Florida, United States, 32405
Status
Recruiting
Location
GSK Investigational Site
Southfield, Michigan, United States, 48034
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
Status
Will Be Recruiting
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Study Complete
Location
GSK Investigational Site
Traverse City, Michigan, United States, 49684
Status
Study Complete
Location
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
Status
Recruiting
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30329
Status
Will Be Recruiting
Location
GSK Investigational Site
Vasvari Pal street 2, H=9023 Gyor, Hungary
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12205
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029-6574
Status
Will Be Recruiting
Location
GSK Investigational Site
San Francisco, California, United States, 94109
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53233
Status
Recruiting
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80110
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Wichita Falls, Texas, United States, 76301
Status
Recruiting
Location
GSK Investigational Site
Northridge, California, United States, 91325
Status
Recruiting
Location
GSK Investigational Site
Szwajcarska 3, Poland, 61-285 Poznań Ul.
Status
Study Complete
Location
GSK Investigational Site
Lido Di Camaiore (LU), Toscana, Italy, 55043
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Study Complete
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Will Be Recruiting
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-28-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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