Last updated: 11/02/2018 23:33:46

Onset Motor Complications using REQUIP CR (ropinirole controlled-release) As Add-on Therapy To L-dopa In Parkinson's

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GSK study ID
101468/228
See study documents
Clinicaltrials.gov ID
NCT00363727
See results summary
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 two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects.
Trial description: This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Number of participants with time to onset of dyskinesia

Timeframe: Up to 2 Years

Secondary outcomes:

Change from Baseline (Day 1) in united PD rating scale (UPDRS) activities of daily living (ADL) score (Part II) at Week 28 and 104

Timeframe: Baseline (Day 1), Week 28 and 104

Change from Baseline (Day 1) UPDRS motor score (UPDRS Part III) over period at Week 28 and Week 104

Timeframe: Baseline (Day 1), Week 28, and Week 104

Number of participants with symptoms of dyskinesia over period

Timeframe: Up to Week 104

Change from Baseline (Day 1) in fatigue score using epworth sleepiness scale (ESS) over period

Timeframe: Baseline (Day 1) and up to Week 104

Number of participants with reduced PD symptom control up to 96 weeks

Timeframe: Up to Week 96

Number of participants with a score of “much improved” or “very much improved” on the clinical global impression of improvement (CGI –I) up to 52 weeks

Timeframe: Up to 52 weeks

Mean change from Baseline (Day 1) in PD quality of life score (PDQ39) scale over period

Timeframe: Baseline (Day 1) and up to 104 weeks

Mini mental status examination (MMSE) score status at screening and Week 104

Timeframe: Screening and Week 104

Change from Baseline (Day 1) in total score on the beck depression inventory (BDI) over period

Timeframe: Baseline (Day 1) and up to Week 104

Change from Baseline (Day 1) in night-time quality of sleep scores of the PD sleep scale (PDSS) over period

Timeframe: Baseline (Day 1), Week 28, 52, 76, and 104

Number of participants of genes variants of interest with and without dyskinesia over period

Timeframe: Up to Week 104

Interventions:
  • Drug: ropinirole controlled-release (REQUIP CR) for RLS
    • Enrollment:
    208
    Primary completion date:
    2006-11-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    R Watts, K Sethi, R Pahwa, B Adams, N Earl. Ropinirole 24-hour prolonged release delays the onset of dyskinesia Compared with carbidopa/levodopa in patients with Parkinson’s disease treated with levodopa. Eur J Neurol. 2007;14 (Issue s1):1-355 .
    R Watts, K Sethi, R Pahwa, B Adams, N Earl. Ropinirole 24-hour prolonged release delays the onset of dyskinesia compared with carbidopa/levodopa in patients with Parkinson’s disease treated with levodopa. Movement Disorders. 2007;22 (Suppl.16):S94/307.
    Medical condition
    Parkinson's Disease, Dyskinesias
    Product
    ropinirole
    Collaborators
    Not applicable
    Study date(s)
    December 2003 to January 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    30 - 70 years
    Accepts healthy volunteers
    No
    • Must be on 600mg or less of levodopa therapy for two years or less.
    • Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening.
    • Current or past history of Dyskinesia.
    • State of dementia or have a MMSE score < 26 at screening.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Must be on 600mg or less of levodopa therapy for two years or less.
    • Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening.
    Exclusion criteria:
    • Current or past history of Dyskinesia.
    • State of dementia or have a MMSE score < 26 at screening.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Des Moines, Iowa, United States, 50309-1426
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Alexandria, Virginia, United States, 22311
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Elkridge, Maryland, United States, 21075
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Asheville, North Carolina, United States, 28801
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23226
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lubbock, Texas, United States, 79410
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boca Raton, Florida, United States, 33486
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83702
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kirkland, Washington, United States, 98034
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kansas City, Kansas, United States, 66160
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27103
    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
    Seattle, Washington, United States, 98101
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Weymouth, Massachusetts, United States, 2190
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Albany, New York, United States, 12205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Traverse City, Michigan, United States, 49684
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504-8456
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33612
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35216
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75235
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53715
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oxnard, California, United States, 93030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gainesville, Florida, United States, 32611
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77081
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Rochester, New York, United States, 14603
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60637
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60611
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Port Charlotte, Florida, United States, 33952
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27516
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sun City, Arizona, United States, 85351
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bingham Farms, Michigan, United States, 48025
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85006
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pembroke Pines, Florida, United States, 33026
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Palm Beach Gardens, Florida, United States, 33410
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newport Beach, California, United States, 92660
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Danbury, Connecticut, United States, 06810
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Northbrook, Illinois, United States, 60062
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Amherst, New York, United States, 14226
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Austell, Georgia, United States, 30106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boulder, Colorado, United States, 80304
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Edison, New Jersey, United States, 08818
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Grand Rapids, Michigan, United States, 49503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Georgia, United States, 31901
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Jose, California, United States, 95126
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tacoma, Washington, United States, 98405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anniston, Alabama, United States, 36207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294
    Status
    Study Complete
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    Location
    GSK Investigational Site
    La Jolla, California, United States, 92037
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94596
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Yarmouth, Massachusetts, United States, 02673
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Austin, Texas, United States, 78756
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, West Virginia, United States, 25301
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newark, Delaware, United States, 19713
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33143
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Eugene, Oregon, United States, 97401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45267-0525
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Lauderdale, Florida, United States, 33145
    Status
    Study Complete
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    Location
    GSK Investigational Site
    LaJolla, California, United States, 92037
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hoffman Estates, Illinois, United States, 60194
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Roanoke, Virginia, United States, 24014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89109
    Status
    Terminated/Withdrawn
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    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-11-01
    Actual study completion date
    2006-11-01

    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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