12-Week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

Condition(s) targeted: Restless Legs

Intervention: ropinirole CR-RLS (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Official title: A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep

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

Primary outcome: Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12.

Secondary outcome: Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.

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

Criteria:

Inclusion criteria:

- provided written informed consent.

- Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria

with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.

- Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS

symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5: 00PM.

- Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria:

- Secondary RLS

- Primary sleep disorder

- Have any medical conditions that may impact efficacy assessments or that may present a

safety concern.

- Pregnant or lactating or women of child-bearing potential who are not practicing an

acceptable method of birth control.

- Use of any prohibited medication.

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Starting date: September 2006
Last updated: June 28, 2007