Last updated: 11/02/2018 23:26:36

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

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GSK study ID
101468/169
See study documents
Clinicaltrials.gov ID
NCT00381472
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Status
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    Location
    GSK Investigational Site
    Bialystok, Poland, 15-276
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294-2041
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lublin, Poland, 20-718
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Augusta, Georgia, United States, 30912
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04103
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Warsaw, Poland, 02-097
    Status
    Study Complete
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    Showing 1 - 6 of 73 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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.

    Additional information about the trial

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