Conditions: Idiopathic Restless Legs Syndrome
Keywords: RLS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 731
Healthy volunteers: no

Brief summary:
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: placebo and pregabalin intervention 2: pramipexol intervention 3: pramipexol intervention 4: Pregabalin intervention 5: pramipexol intervention 6: pramipexol
Intervention descriptions: intervention 1: following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime. intervention 2: following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime. intervention 3: following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.5mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime. intervention 4: pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months intervention 5: pramipexol 0.25 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months intervention 6: pramipexol 0.5 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

Protocol document: