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Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363727
First received: August 7, 2006
Last updated: February 7, 2013
Last verified: June 2012
History of Changes

August 7, 2006
February 7, 2013
December 2003
Not Provided
Time to onset of dyskinesia over 2 years of treatment. [ Time Frame: 2 Years ]
Time to onset of dyskinesia over 2 years of treatment.
Complete list of historical versions of study NCT00363727 on ClinicalTrials.gov Archive Site
UPDRS Incidence of dyskinesia ESS CGI PDQ39 change from baseline MMSE score BDI PDSS Frequency of variants within genes of interest between subjects with and without dyskinesia. [ Time Frame: 2 Years ]
  • UPDRS
  • Incidence of dyskinesia
  • ESS
  • CGI
  • PDQ39
  • change from baseline MMSE score
  • BDI
  • PDSS
  • Frequency of variants within genes of interest between subjects with and without dyskinesia.
Not Provided
Not Provided
 
Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's
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.

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Dyskinesias
  • Parkinson Disease
  • Parkinson's Disease
Drug: ropinirole controlled-release (REQUIP CR) for RLS
Other Name: ropinirole controlled-release (REQUIP CR) for RLS
Not Provided
  • 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.
  • 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 .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
Not Provided
Not Provided

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.
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00363727
101468/228
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP