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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Portland, Oregon 97227
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Atlanta, Georgia 30341
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Columbia, South Carolina 29203
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Laguna Hills, California 92653
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Lebanon, New Hampshire 03756
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Lenexa, Kansas 66215
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Madison, Wisconsin 53792
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Medford, Oregon 97504
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Oak Brook, Illinois 60523
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Walla Walla, Washington 99362
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