XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-02-28

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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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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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

XP13512 (GSK1838262)

Group Type EXPERIMENTAL

XP13512 (GSK1838262)

Intervention Type DRUG

Interventions

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XP13512 (GSK1838262)

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.
* History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
* Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights during the Baseline study period;
* Total RLS severity score of 15 or greater on the International Restless Legs Syndrome Study Group Rating Scale (IRLS rating scale) at Visit 1 and at Visit 2;
* Discontinuation of dopamine agonists and/or gabapentin at least 2 weeks prior to Baseline;
* Discontinuation of other treatments for RLS (e.g., opioids, benzodiazepines) at least 2 weeks prior to Baseline;
* If female of child-bearing potential, the subject must agree to use clinically accepted birth control through completion of the study;
* Body Mass Index of 34 or below;
* Estimated creatinine clearance of at least 60 mL/min;

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