12-Week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12. [ Time Frame: 12 Weeks ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 8
Change from baseline in Wake Time During Sleep (WTDS) at Week 8.

Change History

Complete list of historical versions of study NCT00373542 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. [ Time Frame: 12 Weeks ]

Original Secondary Outcome Measures ^ICMJE

Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.

Descriptive Information

Brief Title ^ICMJE

12-Week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

Official Title ^ICMJE

A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep

Brief Summary

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Restless Legs Syndrome (RLS)

Intervention ^ICMJE

Drug: ropinirole CR-RLS

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

216

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

provided written informed consent.
Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria:

Secondary RLS
Primary sleep disorder
Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
Use of any prohibited medication.

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 ID ^ICMJE

NCT00373542

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

RRL103660

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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