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

• Status: Completed
• Trial end date: 2006-09-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ropinirole

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.