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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 7, 2006
Last updated: April 13, 2015
Last verified: April 2015
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.

Condition Intervention Phase
Parkinson Disease
Parkinson's Disease
Drug: ropinirole controlled-release (REQUIP CR) for RLS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to onset of dyskinesia over 2 years of treatment. [ Time Frame: 2 Years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 209
Study Start Date: December 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00363727

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Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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 .

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363727     History of Changes
Other Study ID Numbers: 101468/228 
Study First Received: August 7, 2006
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
controlled release ropinirole
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016