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

• Drug: Placebo
  
  Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
• Drug: pregabalin
  
  pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
  Other Name: Lyrica
• Drug: pregabalin
  
  pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
  Other Name: Lyrica

• Placebo Comparator: Placebo
  
  Intervention: Drug: Placebo
• Experimental: Pregabalin 150 mg/day
  
  Intervention: Drug: pregabalin
• Experimental: Pregabalin 300 mg/day
  
  Intervention: Drug: pregabalin

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