Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
Condition: Restless Legs Syndrome; Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Ropinirole IR 1 mg; Ropinirole IR 2 mg; Ropinirole IR 1 mg Placebo; Ropinirole IR 2 mg Placebo; Ropinirole CR 2 mg; Ropinirole CR 3 mg; Ropinirole CR 2 mg Placebo; Ropinirole CR 3 mg Placebo
Intervention description: Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.; Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.; Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.; Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.; Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.; Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.; Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.; Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.
Intervention MeSH terms: Ropinirole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: RLS; Ropinirole; Restless Legs Syndrome

Summary:

      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.
    

Eligibility criteria:

        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.