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

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.