MedDataX Logo

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

NCT ID: NCT00363727

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

NCT00381472

Parkinson Disease
COMPLETED PHASE3

A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease

NCT01494532

Parkinson Disease
COMPLETED PHASE4

An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease

NCT00632736

Parkinson Disease Parkinson's Disease
COMPLETED PHASE3

A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

NCT01929317

Parkinson Disease
TERMINATED PHASE3

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa

NCT01154166

Parkinson Disease
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease Parkinson Disease Dyskinesias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ropinirole controlled-release (REQUIP CR) for RLS

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Anniston, Alabama, United States

Site Status

GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Sun City, Arizona, United States

Site Status

GSK Investigational Site

Tucson, Arizona, United States

Site Status

GSK Investigational Site

La Jolla, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Newport Beach, California, United States

Site Status

GSK Investigational Site

Oxnard, California, United States

Site Status

GSK Investigational Site

San Jose, California, United States

Site Status

GSK Investigational Site

Walnut Creek, California, United States

Site Status

GSK Investigational Site

Boulder, Colorado, United States

Site Status

GSK Investigational Site

Danbury, Connecticut, United States

Site Status

GSK Investigational Site

Newark, Delaware, United States

Site Status

GSK Investigational Site

Boca Raton, Florida, United States

Site Status

GSK Investigational Site

Fort Lauderdale, Florida, United States

Site Status

GSK Investigational Site

Gainesville, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Palm Beach Gardens, Florida, United States

Site Status

GSK Investigational Site

Pembroke Pines, Florida, United States

Site Status

GSK Investigational Site

Port Charlotte, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Augusta, Georgia, United States

Site Status

GSK Investigational Site

Austell, Georgia, United States

Site Status

GSK Investigational Site

Columbus, Georgia, United States

Site Status

GSK Investigational Site

Decatur, Georgia, United States

Site Status

GSK Investigational Site

Boise, Idaho, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Hoffman Estates, Illinois, United States

Site Status

GSK Investigational Site

Northbrook, Illinois, United States

Site Status

GSK Investigational Site

Des Moines, Iowa, United States

Site Status

GSK Investigational Site

Kansas City, Kansas, United States

Site Status

GSK Investigational Site

Elkridge, Maryland, United States

Site Status

GSK Investigational Site

South Weymouth, Massachusetts, United States

Site Status

GSK Investigational Site

West Yarmouth, Massachusetts, United States

Site Status

GSK Investigational Site

Bingham Farms, Michigan, United States

Site Status

GSK Investigational Site

Grand Rapids, Michigan, United States

Site Status

GSK Investigational Site

Traverse City, Michigan, United States

Site Status

GSK Investigational Site

Las Vegas, Nevada, United States

Site Status

GSK Investigational Site

Edison, New Jersey, United States

Site Status

GSK Investigational Site

Albany, New York, United States

Site Status

GSK Investigational Site

Amherst, New York, United States

Site Status

GSK Investigational Site

Rochester, New York, United States

Site Status

GSK Investigational Site

Asheville, North Carolina, United States

Site Status

GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Raleigh, North Carolina, United States

Site Status

GSK Investigational Site

Winston-Salem, North Carolina, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Eugene, Oregon, United States

Site Status

GSK Investigational Site

Medford, Oregon, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Lubbock, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Alexandria, Virginia, United States

Site Status

GSK Investigational Site

Richmond, Virginia, United States

Site Status

GSK Investigational Site

Roanoke, Virginia, United States

Site Status

GSK Investigational Site

Kirkland, Washington, United States

Site Status

GSK Investigational Site

Seattle, Washington, United States

Site Status

GSK Investigational Site

Tacoma, Washington, United States

Site Status

GSK Investigational Site

Charleston, West Virginia, United States

Site Status

GSK Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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 .

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

101468/228

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study
NCT00485069 COMPLETED PHASE4
Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
NCT00260793 UNKNOWN PHASE3
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
NCT01485172 COMPLETED PHASE4
A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's
NCT00331149 COMPLETED PHASE3
Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
NCT00823836 COMPLETED PHASE3
Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164
NCT00650104 COMPLETED PHASE3
Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole
NCT00460148 COMPLETED PHASE2
Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia
NCT01092065 COMPLETED PHASE2
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
NCT05766813 RECRUITING PHASE2
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon
NCT01568073 COMPLETED PHASE3
Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
NCT03250117 TERMINATED PHASE1/PHASE2
Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
NCT01435915 COMPLETED PHASE1
A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
NCT03670953 COMPLETED PHASE3
The Role of Dopamine in Motor Learning in Healthy Subjects and Patients With Parkinson's Disease
NCT00032812 COMPLETED
A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.
NCT00903838 TERMINATED PHASE2
A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda
NCT01371682 COMPLETED PHASE1
Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)
NCT00434304 COMPLETED PHASE2
A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)
NCT02807675 COMPLETED PHASE1
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.
NCT03496870 COMPLETED PHASE1
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
NCT00986245 COMPLETED PHASE4
Efficacy of Isradipine in Early Parkinson Disease
NCT02168842 COMPLETED PHASE3
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
NCT00368108 COMPLETED PHASE3
Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease
NCT02542696 COMPLETED PHASE3
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
NCT02469090 COMPLETED PHASE3
Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients
NCT02763137 COMPLETED PHASE2