A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00363857

First received: August 11, 2006

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 11, 2006

Last Updated Date

June 21, 2012

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Improvement in RLS severity rating scale at Week 12

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00363857 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

Official Title ^ICMJE

A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS)

Brief Summary

A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Restless Legs Syndrome
Restless Legs Syndrome (RLS)

Intervention ^ICMJE

Drug: Ropinirole

Other Name: Ropinirole

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

360

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
Patients suffering from other movement disorders (i.e. Parkinson's Disease).
Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
Participation in any clinical drug or device trial in the last three months.

Other inclusion or exclusion criteria to be evaluated by the physician.

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00363857

Other Study ID Numbers ^ICMJE

101468/249

Has Data Monitoring Committee

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top