Clinical trial NCT00363727: Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Parkinson Disease
Dyskinesias
Keywords: dyskinesia
SINEMET
Parkinson's disease
controlled release ropinirole
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 209
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of participants with time to onset of dyskinesia of treatment over 104 weeks (2 years)
timeFrame: Up to 2 Years
Secondary outcomes:
measure: 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: At Weeks 28 and 104
measure: 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
measure: Number of participants with symptoms of dyskinesia over period
timeFrame: Upto week 106
measure: Change from Baseline (Day 1) in fatigue score using epworth sleepiness scale (ESS) over period
timeFrame: Baseline (Day 1) and up to Week 104
measure: Percentage of participants with reduced PD symptom control up to 96 weeks
timeFrame: Up to Week 96
measure: Percentage 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
measure: Mean change from Baseline (Day 1) in PD quality of life score (PDQ39) scale over period
timeFrame: Up to 104 weeks
measure: Mini mental status examination (MMSE) score status at screening and Week 104
timeFrame: Screening and Week 104
measure: 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
measure: Change from Baseline (Day 1) in night-time quality of sleep scores of the PD sleep scale (PDSS) over period
timeFrame: Week 28, 52, 76, and 104
measure: Percentage of participants of genes variants of interest with and without dyskinesia over period
timeFrame: Up to Week 104
Other outcomes:
Locations:
city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Sun City
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: GSK Investigational Site
state: California
city: LaJolla
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: Oxnard
country: United States
facility: GSK Investigational Site
state: California
city: San Jose
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Boulder
country: United States
facility: GSK Investigational Site
state: Colorado
city: Danbury
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Newark
country: United States
facility: GSK Investigational Site
state: Delaware
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Austell
country: United States
facility: GSK Investigational Site
state: Georgia
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: GSK Investigational Site
state: Illinois
city: Northbrook
country: United States
facility: GSK Investigational Site
state: Illinois
city: Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Elkridge
country: United States
facility: GSK Investigational Site
state: Maryland
city: South Weymouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: West Yarmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: GSK Investigational Site
state: Michigan
city: Grand Rapids
country: United States
facility: GSK Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: GSK Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Edison
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Amherst
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Asheville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Lubbock
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Alexandria
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Kirkland
country: United States
facility: GSK Investigational Site
state: Washington
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Charleston
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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 .
citation: 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.