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

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.