Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)



Status:Completed
Conditions:Restless Leg Syndrome, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:18 - 79
Updated:3/17/2019
Start Date:November 14, 2005
End Date:September 21, 2006

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A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting From Ropinirole Immediate Release (IR) to Ropinirole Controlled Release for RLS (CR-RLS) Formulation (Formerly Ropinirole Extended Release [XR]) in Patients With Restless Legs Syndrome (RLS)

This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed
dose conversion recommendations for RLS subjects converting from ropinirole immediate release
to ropinirole controlled-release for RLS.


Inclusion Criteria:

- Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.

- Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of
ropinirole IR given once daily.

- Subjects with RLS symptoms during both the evening and night or night time only.

- Subjects who have given written informed consent to participate.

Exclusion Criteria:

- Subjects who require treatment of daytime RLS symptoms.

- Signs of secondary RLS, serum ferritin level less than 10 mcg/L.

- Movement Disorders, Clinically significant or unstable medical conditions.

- Abnormal labs, electrocardiogram (ECG) or physical findings.

- Receiving prohibited medications.

- Sleeping habits incompatible with study design.

- Intolerance to ropinirole or other dopamine agonist.

- Pregnant or lactating.

- Women of child-bearing potential who are not practicing an acceptable method of birth
control.
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30
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Oxnard, California 93030
66
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Oxnard, CA
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Atlanta, Georgia 30341
1922
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Atlanta, GA
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Baton Rouge, Louisiana 70809
1589
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Baton Rouge, LA
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Bingham Farms, Michigan 48025
1956
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Bingham Farms, MI
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Boca Raton, Florida 33486
2311
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Boca Raton, FL
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Cherry Hill, New Jersey 08003
2382
mi
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Cherry Hill, NJ
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Columbia, South Carolina 29203
2102
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Columbia, SC
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Dallas, Texas 75230
1223
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Dallas, TX
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Dayton, Ohio 45420
1900
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Dayton, OH
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Greenville, North Carolina 27858
2290
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Greenville, NC
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Laguna Hills, California 92653
38
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Laguna Hills, CA
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Las Vegas, Nevada 89102
214
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Las Vegas, NV
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Lebanon, New Hampshire 03756
2515
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Lebanon, NH
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Lenexa, Kansas 66215
1331
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Lenexa, KS
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Madison, Wisconsin 53792
1654
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Madison, WI
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Medford, Oregon 97504
628
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Medford, OR
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New York, New York 10032
2435
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New York, NY
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Oak Brook, Illinois 60523
1714
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Oak Brook, IL
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Oklahoma City, Oklahoma 73112
1161
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Oklahoma City, OK
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Pasadena, California 91105
9
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Pasadena, CA
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Plainview, New York 11803
2460
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Plainview, NY
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Portland, Oregon 97227
829
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Portland, OR
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Reseda, California 91355
41
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Reseda, CA
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Saint Petersburg, Florida 33713
2128
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Saint Petersburg, FL
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San Antonio, Texas 78258
1184
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San Antonio, TX
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Springfield, Massachusetts 01199
2500
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Springfield, MA
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Tacoma, Washington 98405
939
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Tacoma, WA
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Tampa, Florida 33612
2134
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Tampa, FL
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Toms River, New Jersey 08755
2425
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Toms River, NJ
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Walla Walla, Washington 99362
828
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Walla Walla, WA
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