Long-Term Study of XP13512 vs. Placebo in Patients With Restless Legs Syndrome - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00311363

Purpose

The primary objective of this trial is to assess the maintenance of efficacy of XP13512 taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: XP13512 Drug: Placebo	Phase III

MedlinePlus related topics: Restless Legs

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Long-Term Study of XP13512 Versus Placebo Treatment Assessing Maintenance of Efficacy and Safety in Patients With Restless Legs Syndrome

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The proportion of RLS patients relapsing during the double-blind treatment period. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator and Patient Clinical Global Impression (CGI) of Improvement at the end of treatment [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Change in the IRLS score at the end of treatment [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Subjective measures of sleep and quality of life. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment:	327
Study Start Date:	April 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1200 mg XP13512	Drug: XP13512 1200 mg XP13512, orally, once daily for 24 weeks followed by either 1200 mg XP13512 or placebo, orally, once daily for an additional 12 weeks
2: Placebo Comparator Placebo	Drug: Placebo Placebo, orally, once daily for 12 weeks following single blind 24-week phase

Eligibility

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

Criteria

Inclusion Criteria:

Patients with primary RLS, based on the International RLS Study Group 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311363

Locations

United States, California
XenoPort, Inc. Rise and Shine Clinical Trial Central Study Call Center
Santa Clara, California, United States, 95051

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Pierre Tran, MD

XenoPort, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	XenoPort, Inc. ( Jay Huff, MD, VP of Clinical Development )
Study ID Numbers:	111461
Study First Received:	April 3, 2006
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00311363 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Mental Disorders
Restless Legs Syndrome
Neurologic Manifestations
Dyssomnias

Sleep Disorders
Psychomotor Agitation
Neurobehavioral Manifestations
Dyskinesias
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Disease
Nervous System Diseases
Parasomnias
Dyssomnias
Sleep Disorders
Psychomotor Agitation
Dyskinesias
Sleep Disorders, Intrinsic

Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome
Restless Legs Syndrome
Psychomotor Disorders
Neurologic Manifestations
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on May 07, 2009