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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00373542
Other study ID # RRL103660
Secondary ID
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
Health authority
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.

Study Design


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
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