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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome (RLS); Restless Legs Syndrome

Treatments: Drug: ropinirole Extended Release (XR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314860

101468/204

Details and patient eligibility

About

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

Enrollment: 568 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind