Back to resultsXP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.
Primary Purpose
Restless Legs Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
XP13512 (GSK1838262)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
XP13512 (GSK1838262)
Arm Description
Outcomes
Primary Outcome Measures
The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.
The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement
Secondary Outcome Measures
Onset of efficacy. Subjective measures of sleep.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00298623
Brief Title
XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
XenoPort, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
XP13512 (GSK1838262)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
XP13512 (GSK1838262)
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score.
Time Frame
12-week treatment period
Title
The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement
Time Frame
12-week treatment period
Secondary Outcome Measure Information:
Title
Onset of efficacy. Subjective measures of sleep.
Time Frame
12-week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19238802
Citation
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.
Results Reference
background
PubMed Identifier
27288210
Citation
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.
Results Reference
derived
PubMed Identifier
27067343
Citation
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.
Results Reference
derived
PubMed Identifier
26788345
Citation
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.
Results Reference
derived
PubMed Identifier
21527006
Citation
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.
Results Reference
derived
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XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.
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