XP13512 vs. Placebo 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

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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XP13512 600MG

XP13512 600MG ONCE DAILY

Group Type EXPERIMENTAL

XP13512 600MG

Intervention Type DRUG

XP13512 600MG ONCE DAILY

XP13512 1200MG

XP13512 1200MG ONCE DAILY

Group Type EXPERIMENTAL

XP13512 1200MG

Intervention Type DRUG

XP13512 1200MG ONCE DAILY

Placebo

PLACEBO ONCE DAILY

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

PLACEBO ONCE DAILY

Interventions

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XP13512 600MG

XP13512 600MG ONCE DAILY

Intervention Type DRUG

XP13512 1200MG

XP13512 1200MG ONCE DAILY

Intervention Type DRUG

PLACEBO

PLACEBO ONCE DAILY

Intervention Type DRUG

Other Intervention Names

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GSK1838262 Gabapentin Enacarbil GSK1838262 Gabapentin Enacarbil

Eligibility Criteria

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Inclusion Criteria

* Patients with primary RLS, based on the International RLS Study Diagnostic Criteria.

Exclusion Criteria

* A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
* Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias);
* Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
* Pregnant or lactating women;
* Women of childbearing potential who are not practicing an acceptable method of birth control.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No