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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

581 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-12-31

Brief Summary

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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).

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Detailed Description

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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 \[NCT01332318\]).

Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XP13512 (GEn)

1200 mg XP13512, orally, once daily for 52 weeks

Group Type EXPERIMENTAL

XP13512 (GEn)

Intervention Type DRUG

1200 mg XP13512, orally, once daily for 52 weeks

Interventions

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XP13512 (GEn)

1200 mg XP13512, orally, once daily for 52 weeks

Intervention Type DRUG

Other Intervention Names

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GSK1838262 Gabapentin Enacarbil

Eligibility Criteria

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Inclusion Criteria

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