12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any secondary RLS
• Current augmentation due to RLS treatment
• Placebo responders identified during the placebo run-in