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

Condition(s) targeted: Restless Legs Syndrome

Intervention: ropinirole Extended Release (XR) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical trials, MD, Study Director, Affiliation: GlaxoSmithKline

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

Official title: A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms

Secondary outcome: To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

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.

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Starting date: February 2006
Last updated: September 25, 2007