Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-Release) As Add-on Therapy To L-Dopa In Parkinson's - Full Text View

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
Parkinson's Disease Dyskinesias	Drug: ropinirole controlled-release (REQUIP CR) for RLS	Phase III

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

ChemIDplus related topics:

Ropinirole Ropinirole hydrochloride Levodopa Sinemet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

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 2005

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 65 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	101468/228
First Received:	August 7, 2006
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00363727
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

dyskinesia

controlled release ropinirole

SINEMET

Parkinson's disease

Study placed in the following topic categories:

Ropinirole

Levodopa

Ganglion Cysts

Basal Ganglia Diseases

Central Nervous System Diseases

Brain Diseases

Neurodegenerative Diseases

Dyskinesias

Signs and Symptoms

Dopamine

Parkinson Disease

Movement Disorders

Sinemet

Dihydroxyphenylalanine

Neurologic Manifestations

Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Antiparkinson Agents

Dopamine Agents

Dopamine Agonists

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00363727