Clinical trial NCT00373542: 12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Keywords: Restless Legs Syndrome
ropinirole
polysomnography
RLS
PSG
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Jasper
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Greenwood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: GSK Investigational Site
state: Colorado
city: Brandon
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Austell
country: United States
facility: GSK Investigational Site
state: Georgia
city: Macon
country: United States
facility: GSK Investigational Site
state: Georgia
city: Elk Grove Village
country: United States
facility: GSK Investigational Site
state: Illinois
city: Normal
country: United States
facility: GSK Investigational Site
state: Illinois
city: Danville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Topeka
country: United States
facility: GSK Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: GSK Investigational Site
state: Maine
city: Brighton
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Toms River
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dublin
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Corvallis
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Duncansville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Lafayette Hill
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Walla Walla
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: