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



Status:Completed
Conditions:Restless Leg Syndrome, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:18 - 79
Updated:10/14/2017
Start Date:October 2006
End Date:June 2007

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.
We found this trial at
44
sites
GSK Investigational Site
Topeka, Kansas 66604
?
mi
from
Topeka, KS
Click here to add this to my saved trials
GSK Investigational Site
Anaheim, California 92807
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
GSK Investigational Site
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
GSK Investigational Site
Auburn, Maine 04210
?
mi
from
Auburn, ME
Click here to add this to my saved trials
GSK Investigational Site
Austell, Georgia 30106
?
mi
from
Austell, GA
Click here to add this to my saved trials
GSK Investigational Site
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
GSK Investigational Site
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
GSK Investigational Site
Brighton, Massachusetts 02135
?
mi
from
Brighton, MA
Click here to add this to my saved trials
GSK Investigational Site
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
GSK Investigational Site
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
GSK Investigational Site
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
GSK Investigational Site
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
GSK Investigational Site
Corvallis, Oregon 97330
?
mi
from
Corvallis, OR
Click here to add this to my saved trials
GSK Investigational Site
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
GSK Investigational Site
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
GSK Investigational Site
Danville, Indiana 46122
?
mi
from
Danville, IN
Click here to add this to my saved trials
GSK Investigational Site
Dublin, Ohio 43016
?
mi
from
Dublin, OH
Click here to add this to my saved trials
GSK Investigational Site
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
GSK Investigational Site
Elk Grove Village, Illinois 60007
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
GSK Investigational Site
Greenville, North Carolina 27858
?
mi
from
Greenville, NC
Click here to add this to my saved trials
GSK Investigational Site
Greenwood, Colorado 80111
?
mi
from
Greenwood, CO
Click here to add this to my saved trials
GSK Investigational Site
Jasper, Alabama 35501
?
mi
from
Jasper, AL
Click here to add this to my saved trials
GSK Investigational Site
Lafayette, Louisiana 70503
?
mi
from
Lafayette, LA
Click here to add this to my saved trials
GSK Investigational Site
Lafayette Hill, Pennsylvania 19444
?
mi
from
Lafayette Hill, PA
Click here to add this to my saved trials
GSK Investigational Site
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
GSK Investigational Site
Lenexa, Kansas 66215
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
GSK Investigational Site
Lexington, Kentucky 40504
?
mi
from
Lexington, KY
Click here to add this to my saved trials
GSK Investigational Site
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
GSK Investigational Site
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
GSK Investigational Site
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
GSK Investigational Site
Normal, Illinois 61761
?
mi
from
Normal, IL
Click here to add this to my saved trials
GSK Investigational Site
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
GSK Investigational Site
Pembroke Pines, Florida 33028
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
GSK Investigational Site
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
GSK Investigational Site
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
GSK Investigational Site
San Antonio, Texas 78258
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
GSK Investigational Site
San Diego, California 92111
?
mi
from
San Diego, CA
Click here to add this to my saved trials
GSK Investigational Site
St. Louis, Missouri 63110
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
GSK Investigational Site
St. Petersburg, Florida 33707
?
mi
from
St. Petersburg, FL
Click here to add this to my saved trials
GSK Investigational Site
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
GSK Investigational Site
Tulsa, Oklahoma 74105
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
GSK Investigational Site
Tuscaloosa, Alabama 35401
?
mi
from
Tuscaloosa, AL
Click here to add this to my saved trials
GSK Investigational Site
Walla Walla, Washington 99362
?
mi
from
Walla Walla, WA
Click here to add this to my saved trials
GSK Investigational Site
Wheat Ridge, Colorado 80033
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials