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

Restless Legs Syndrome Clinical Trial

— (CR-RLS)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373542
• Other study ID #: RRL103660
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2006
• Last updated: October 27, 2016
• Start date: October 2006
• Est. completion date: June 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Restless Legs Syndrome (RLS)
• Syndrome

Intervention

Drug:
• ropinirole CR-RLS

Locations

Country	Name	City	State
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Auburn	Maine
United States	GSK Investigational Site	Austell	Georgia
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Brighton	Massachusetts
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Corvallis	Oregon
United States	GSK Investigational Site	Crestview Hills	Kentucky
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Danville	Indiana
United States	GSK Investigational Site	Dublin	Ohio
United States	GSK Investigational Site	Duncansville	Pennsylvania
United States	GSK Investigational Site	Elk Grove Village	Illinois
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Greenwood	Colorado
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Lafayette Hill	Pennsylvania
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lenexa	Kansas
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Macon	Georgia
United States	GSK Investigational Site	Normal	Illinois
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Toms River	New Jersey
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Tuscaloosa	Alabama
United States	GSK Investigational Site	Walla Walla	Washington
United States	GSK Investigational Site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 Weeks
Secondary	Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.		12 Weeks

External Links

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