Conditions: Restless Legs Syndrome
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 581
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).

Detailed description:
Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil \[GEn\]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).

Arms:
arm 1: 1200 mg XP13512, orally, once daily for 52 weeks

Interventions: intervention 1: XP13512 (GEn)
Intervention descriptions: intervention 1: 1200 mg XP13512, orally, once daily for 52 weeks

Protocol document: