Conditions: Restless Legs Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 325
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Detailed description:
This was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of XP13512 in subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive 1 of 3 once daily oral doses of XP13512 1200 mg, XP13512 600 mg, or placebo. The primary study objective was to compare the efficacy of XP13512 1200 mg taken once daily for 12 weeks versus placebo. The secondary study objectives were to assess the efficacy of XP13512 600 mg taken once daily for the reatment of RLS and to assess the onset of treatment benefits and improvement in sleep, pain, mood, quality of life, and safety and tolerability of both XP13512 1200 mg and 600 mg.

Arms:
arm 1: XP13512 600MG ONCE DAILY arm 2: XP13512 1200MG ONCE DAILY arm 3: PLACEBO ONCE DAILY

Interventions: intervention 1: XP13512 600MG intervention 2: XP13512 1200MG intervention 3: PLACEBO
Intervention descriptions: intervention 1: XP13512 600MG ONCE DAILY intervention 2: XP13512 1200MG ONCE DAILY intervention 3: PLACEBO ONCE DAILY

Protocol document: