Conditions: Restless Legs Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief summary:
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of an agent known to have sedative properties, while the other 3 groups received a DPH placebo.

Detailed description:
This study was a multicenter, randomized, double blind, active and placebo controlled, parallel group study. Eligible subjects were randomized in a 1:1:1:1 ratio to 1 of the following 4 treatment groups:

A) XP13512 Placebo + Diphenhydramine Placebo (Pbo) B) XP13512 1200 mg/day + Diphenhydramine Placebo (1200 mg) C) XP13512 1800 mg/day + Diphenhydramine Placebo (1800 mg) D) XP13512 Placebo + 50 mg Diphenhydramine (Pbo/DPH)

Arms:
arm 1: XP13512 Placebo + Diphenhydramine Placebo arm 2: XP13512 1200 mg/day + Diphenhydramine Placebo arm 3: XP13512 1800 mg/day + Diphenhydramine Placebo arm 4: XP13512 Placebo + 50 mg Diphenhydramine

Interventions: intervention 1: XP13512 intervention 2: Diphenhydramine intervention 3: Placebo
Intervention descriptions: intervention 1: XP13512 once daily for 16 days intervention 2: one 50 mg dose of diphenhydramine (DPH) on day 16 intervention 3: XP13512 placebo once daily for 16 days

Protocol document: