Conditions: Restless Legs Syndrome
Keywords: pregabalin, RLS, efficacy, safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

Brief summary:
To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Detailed description:

Arms:
arm 1: Placebo arm 2: investigational treatment arm 3: investigational treatment arm 4: investigational treatment arm 5: investigational treatment arm 6: investigational treatment

Interventions: intervention 1: placebo intervention 2: Pregabalin intervention 3: Pregabalin intervention 4: Pregabalin intervention 5: Pregabalin intervention 6: Pregabalin
Intervention descriptions: intervention 1: Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks intervention 2: 50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 3: 100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 4: 150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 5: 300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks intervention 6: 450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

Protocol document: