XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.

XenoPort

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: XP13512 (GEn)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333359

111490

Details and patient eligibility

About

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).

Full 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]).

Enrollment: 581 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have successfully completed one of the following studies: XP052 (110963 [NCT00298623]), XP053 (111460 [NCT00365352]), XP081 (111462 [NCT01332305]), and XP083 (111463 [NCT01332318]).

Exclusion criteria

• Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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581 participants in 1 patient group

XP13512 (GEn)

Experimental group

Description:

1200 mg XP13512, orally, once daily for 52 weeks

Treatment:

Drug: XP13512 (GEn)