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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
  Purpose

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
Dyskinesias
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:

U.S. FDA Resources

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: 350
Study Start Date: December 2003
Intervention Details:
    Drug: ropinirole controlled-release (REQUIP CR) for RLS
    Other Name: ropinirole controlled-release (REQUIP CR) for RLS
  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363727

  Show 70 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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. 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: February 7, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013