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

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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.
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Lexington, Kentucky 40504
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Anaheim, California 92807
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Atlanta, Georgia 30341
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Auburn, Maine 04210
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Austell, Georgia 30106
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Baton Rouge, Louisiana 70809
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Brandon, Florida 33511
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Brighton, Massachusetts 02135
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Charlotte, North Carolina 28203
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Cincinnati, Ohio 45229
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Cleveland, Ohio 44195
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Columbia, South Carolina 29203
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Corvallis, Oregon 97330
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Crestview Hills, Kentucky 41017
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Dallas, Texas 75230
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Danville, Indiana 46122
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Dublin, Ohio 43016
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Duncansville, Pennsylvania 16635
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Elk Grove Village, Illinois 60007
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Greenville, North Carolina 27858
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Greenwood, Colorado 80111
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Jasper, Alabama 35501
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Lafayette, Louisiana 70503
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Lafayette Hill, Pennsylvania 19444
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Las Vegas, Nevada 89102
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Lenexa, Kansas 66215
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Little Rock, Arkansas 72205
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Louisville, Kentucky 40202
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Macon, Georgia 31201
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Normal, Illinois 61761
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Oklahoma City, Oklahoma 73112
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Pembroke Pines, Florida 33028
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St. Louis, Missouri 63110
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St. Petersburg, Florida 33707
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Topeka, Kansas 66604
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