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

NCT00298623 | Completed Phase 3 DMC

• 1 other identifier: 110963
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

• The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.

  12-week treatment period

• 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

Secondary Outcomes (1)

• Onset of efficacy. Subjective measures of sleep.

  12-week treatment period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: placebo

XP13512 (GSK1838262)

EXPERIMENTAL

Drug: XP13512 (GSK1838262)

Interventions

XP13512 (GSK1838262) DRUG

XP13512 (GSK1838262)

placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• XenoPort, Inc.: lead

Related Publications (5)

• 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. doi: 10.1093/sleep/32.2.159.

  PMID: 19238802 BACKGROUND

• Ahmed M, Hays R, Steven Poceta J, Jaros MJ, Kim R, Shang G. Effect of Gabapentin Enacarbil on Individual Items of the International Restless Legs Study Group Rating Scale and Post-sleep Questionnaire in Adults with Moderate-to-Severe Primary Restless Legs Syndrome: Pooled Analysis of 3 Randomized Trials. Clin Ther. 2016 Jul;38(7):1726-1737.e1. doi: 10.1016/j.clinthera.2016.05.008. Epub 2016 Jun 7.

  PMID: 27288210 DERIVED

• Avidan AY, Lee D, Park M, Jaros MJ, Shang G, Kim R. The Effect of Gabapentin Enacarbil on Quality of Life and Mood Outcomes in a Pooled Population of Adult Patients with Moderate-to-Severe Primary Restless Legs Syndrome. CNS Drugs. 2016 Apr;30(4):305-16. doi: 10.1007/s40263-016-0329-4.

  PMID: 27067343 DERIVED

• Ondo WG, Hermanowicz N, Borreguero DG, Jaros MJ, Kim R, Shang G. Effect of prior exposure to dopamine agonists on treatment with gabapentin enacarbil in adults with moderate-to-severe primary restless legs syndrome: pooled analyses from 3 randomized trials. J Clin Mov Disord. 2015 Mar 30;2:9. doi: 10.1186/s40734-015-0018-3. eCollection 2015.

  PMID: 26788345 DERIVED

• Canafax DM, Bhanegaonkar A, Bharmal M, Calloway M. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials. BMC Neurol. 2011 Apr 28;11:48. doi: 10.1186/1471-2377-11-48.

  PMID: 21527006 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 2, 2006
• Study Start: March 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: May 14, 2013

Record last verified: 2011-05