Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in Restless Legs Syndrome (RLS) and Associated Sleep Disturbance - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00748098

Purpose

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

Condition	Intervention	Phase
Restless Legs Syndrome (RLS)	Drug: GSK1838262 Extended Release Tablets Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Official Title:	Study RXP110908, a Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in the Treatment of Restless Legs Syndrome (RLS) and Associated Sleep Disturbance

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs Sleep Disorders

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline to end of each treatment period in Wake Time During Sleep (WTDS) measured by polysomnography [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to end of each treatment period in Periodic Limb Movements associated with Arousal per hour (PLMAI) measured by polysomnography [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	136
Study Start Date:	October 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GSK1838262:placebo GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2	Drug: GSK1838262 Extended Release Tablets GSK1838262 extended release tablets Drug: Placebo Placebo
Placebo:GSK1838262 Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2	Drug: GSK1838262 Extended Release Tablets GSK1838262 extended release tablets Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Provided written informed consent.
Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
Have history of RLS symptoms at least 15 nights/month.
Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).

Exclusion criteria:

Secondary RLS
Primary sleep disorder
Sleep apnea
Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
Use of any prohibited medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748098

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Locations

United States, Alabama
GSK Investigational Site
Jasper, Alabama, United States, 35501
United States, California
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
Redlands, California, United States, 92373
GSK Investigational Site
Burlingame, California, United States, 94010
GSK Investigational Site
San Diego, California, United States, 92121
United States, Florida
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Macon, Georgia, United States, 31201
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66214
GSK Investigational Site
Overland Park, Kansas, United States, 66211
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40509
GSK Investigational Site
Crestview Hills, Kentucky, United States, 41017
United States, Maryland
GSK Investigational Site
Chevy Chase, Maryland, United States, 20815
GSK Investigational Site
Baltimore, Maryland, United States, 21224
United States, Massachusetts
GSK Investigational Site
Brighton, Massachusetts, United States, 02135
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, New York
GSK Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
GSK Investigational Site
Greenville, North Carolina, United States, 27835
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
GSK Investigational Site
Dublin, Ohio, United States, 43017
GSK Investigational Site
Cleveland, Ohio, United States, 44130
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78756
United States, Washington
GSK Investigational Site
Walla Walla, Washington, United States, 99362

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	RXP110908
Study First Received:	September 5, 2008
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00748098 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Restless Legs Syndrome
RLS
GSK1838262
XP13512

polysomnography
PSG
sleep disturbance
gabapentin enacarbil

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Gabapentin
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Antiparkinson Agents
Sleep Disorders
Excitatory Amino Acid Agents
Psychomotor Agitation
Sleep Disorders, Intrinsic
Membrane Transport Modulators
Signs and Symptoms
Pathologic Processes

Mental Disorders
Sensory System Agents
Syndrome
Therapeutic Uses
Restless Legs Syndrome
Psychomotor Disorders
Analgesics
Neurobehavioral Manifestations
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Disease
Parasomnias
Nervous System Diseases
Central Nervous System Depressants
Dyssomnias

ClinicalTrials.gov processed this record on November 20, 2009