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

Restless Legs Syndrome Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298623
• Other study ID #: 110963
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2006
• Last updated: May 10, 2013
• Start date: March 2006
• Est. completion date: February 2007

Study information

• Verified date: May 2011
• Source: XenoPort, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• XP13512 (GSK1838262)

Other:
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XenoPort, Inc.

References & Publications (1)

Kushida CA, Walters AS, Becker P, Thein SG, Perkins AT, Roth T, Canafax D, Barrett RW; XP021 Study Group. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep. 2009 Feb;32(2):159-68. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.		12-week treatment period	No
Primary	The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement		12-week treatment period	No
Secondary	Onset of efficacy. Subjective measures of sleep.		12-week treatment period	No