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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00225862

First received: June 30, 2005

Last updated: September 29, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

September 29, 2010

Start Date ^ICMJE

January 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase. [ Time Frame: 12 Weeks ]

Original Primary Outcome Measures ^ICMJE

Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.

Change History

Complete list of historical versions of study NCT00225862 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. [ Time Frame: 12 Weeks ]

Original Secondary Outcome Measures ^ICMJE

Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A 12-week, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)

Brief Summary

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.

Detailed Description

Not Provided

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 (RLS)

Intervention ^ICMJE

Drug: ropinirole

Other Name: ropinirole

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

140

Completion Date

December 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Â 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).
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

NCT00225862

Other Study ID Numbers ^ICMJE

100310

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2010

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

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