RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ropinirole

Criteria

Inclusion Criteria:

• Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.

• Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.

Exclusion criteria:

• Signs of secondary RLS.

• Primary sleep disorder or movement disorder other than RLS.

• Unstable medical conditions.

• Inability to tolerate dopamine agonists or dopamine antagonists.

• Unwilling to discontinue any medications currently being taken to treat RLS symptoms.