MedDataX Logo

A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

NCT ID: NCT00225862

Last Updated: 2016-09-15

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-12-31

Brief Summary

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

A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

Related Clinical Trials

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

Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

NCT00197080

Restless Legs Syndrome
COMPLETED PHASE3

Long-term Study Of Ropinirole In Restless Legs Syndrome

NCT00329602

Restless Legs Syndrome
COMPLETED PHASE4

RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

NCT00314860

Restless Legs Syndrome Restless Legs Syndrome (RLS)
COMPLETED PHASE3

Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome

NCT00355641

Restless Legs Syndrome
COMPLETED PHASE3

Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

NCT00256854

Restless Legs Syndrome Restless Legs Syndrome (RLS)
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.

Restless Legs Syndrome

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

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Patients diagnosed with Restless Legs Syndrome (RLS).
* Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).
* Patients must give written informed consent prior to any specific study procedures.

Exclusion Criteria

* Patients with a primary sleep disorder other than RLS.
* Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 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

Alabaster, Alabama, United States

Site Status

GSK Investigational Site

Jasper, Alabama, United States

Site Status

GSK Investigational Site

Peoria, Arizona, United States

Site Status

GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Northridge, California, United States

Site Status

GSK Investigational Site

Oxnard, California, United States

Site Status

GSK Investigational Site

Redondo Beach, California, United States

Site Status

GSK Investigational Site

Santa Monica, California, United States

Site Status

GSK Investigational Site

Fairfield, Connecticut, United States

Site Status

GSK Investigational Site

Largo, Florida, United States

Site Status

GSK Investigational Site

Pembroke Pines, Florida, United States

Site Status

GSK Investigational Site

St. Petersburg, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Elk Grove Village, Illinois, United States

Site Status

GSK Investigational Site

Flossmoor, Illinois, United States

Site Status

GSK Investigational Site

Topeka, Kansas, United States

Site Status

GSK Investigational Site

Baton Rouge, Louisiana, United States

Site Status

GSK Investigational Site

Frederick, Maryland, United States

Site Status

GSK Investigational Site

Newton, Massachusetts, United States

Site Status

GSK Investigational Site

Newton Center, Massachusetts, United States

Site Status

GSK Investigational Site

Bingham Farms, Michigan, United States

Site Status

GSK Investigational Site

Edison, New Jersey, United States

Site Status

GSK Investigational Site

Albuquerque, New Mexico, United States

Site Status

GSK Investigational Site

Albuquerque, New Mexico, United States

Site Status

GSK Investigational Site

Amherst, New York, United States

Site Status

GSK Investigational Site

New Hyde Park, New York, United States

Site Status

GSK Investigational Site

Raleigh, North Carolina, United States

Site Status

GSK Investigational Site

Concinnati, Ohio, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Lafayette Hill, Pennsylvania, United States

Site Status

GSK Investigational Site

Columbia, South Carolina, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Plano, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Walla Walla, Washington, United States

Site Status

GSK Investigational Site

Wenatchee, Washington, United States

Site Status

Countries

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

United States

Study Documents

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

Document Type: Statistical Analysis Plan

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: Individual Participant Data Set

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

Document Type: Dataset Specification

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: Study Protocol

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.

100310

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
NCT01569464 COMPLETED PHASE3
Ropinirole Tablets In Young Patients With Restless Legs Syndrome
NCT00140712 COMPLETED PHASE1
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
NCT00419692 COMPLETED PHASE1
Effect of Ropinirole on Spinal Cord Reflexes and Restless Legs Syndrome
NCT00051961 COMPLETED
Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome
NCT00530790 COMPLETED PHASE2
A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
NCT00627003 COMPLETED PHASE3
SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole
NCT00344994 COMPLETED PHASE4
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
NCT00806026 COMPLETED PHASE3
A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
NCT00152958 COMPLETED PHASE3
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
NCT01192503 TERMINATED PHASE2/PHASE3
Bupropion and Restless Legs Syndrome
NCT00621517 COMPLETED PHASE2/PHASE3
Treatment of Restless Legs Syndrome With the Hypocretin Antagonist Suvorexant
NCT03755310 UNKNOWN PHASE2
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
NCT00135993 COMPLETED PHASE3
Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)
NCT00996944 TERMINATED PHASE2
Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome
NCT02025608 COMPLETED PHASE4
Switching From Oral Dopamine Agonists to Rotigotine
NCT01976871 COMPLETED PHASE4
Rotigotine Restless Legs Syndrome Dose Finding Trial
NCT00243217 COMPLETED PHASE2
Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
NCT01455012 COMPLETED PHASE4
Clinical Trial Assessing the Efficacy and Safety of BP1.4979 in Restless Legs Syndrome
NCT03345953 TERMINATED PHASE2
Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome
NCT00136045 COMPLETED PHASE3
Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
NCT00895232 COMPLETED PHASE2
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
NCT00389831 COMPLETED PHASE2
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
NCT03728933 TERMINATED PHASE3
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
NCT03218969 UNKNOWN PHASE1/PHASE2
Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
NCT00676403 COMPLETED PHASE2