- Idiopathic Restless Legs Syndrome with the presence of all four clinical
manifestations of RLS:
- RLS symptoms occur predominantly in the evening
- RLS history at least 6 months
- International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to
15 at the beginning and the end of placebo run-in
- Have greater than or equal to 15 nights with RLS symptoms in the month prior to
screening
- Any secondary RLS
- Current augmentation due to RLS treatment
- Placebo responders identified during the placebo run-in