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

Sponsored by:	XenoPort, Inc.
Information provided by:	XenoPort, Inc.
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 XenoPort, Inc.:

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

XenoPort, Inc.

Investigators

Study Director:

Pierre Tran, MD

XenoPort, Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	XenoPort, Inc. ( Jay Huff, MD, VP of Clinical Development )
Study ID Numbers:	XP060
Study First Received:	April 3, 2006
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00311363
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Ekbom syndrome
Mental Disorders
Restless Legs Syndrome
Neurologic Manifestations
Dyssomnias

Sleep Disorders
Psychomotor Agitation
Neurobehavioral Manifestations
Dyskinesias
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

Parasomnias
Nervous System Diseases
Psychomotor Disorders

ClinicalTrials.gov processed this record on January 15, 2009