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

Conditions

Restless Legs Syndrome

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).

Ahmed M, Hays R, Steven Poceta J, Jaros MJ, Kim R, Shang G.

2016-06-077 citations

10.1016/j.clinthera.2016.05.008

The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials.

Hermanowicz N, Ellenbogen A, Irving G, Buchfuhrer M, Jaros MJ, Shang G, Kim R.

2016-05-014 citations

10.1007/s40263-016-0333-8

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.

Avidan AY, Lee D, Park M, Jaros MJ, Shang G, Kim R.

2016-04-016 citations

10.1007/s40263-016-0329-4

Efficacy of gabapentin enacarbil in adult patients with severe primary restless legs syndrome.

Lee DO, Buchfuhrer MJ, Garcia-Borreguero D, Avidan AY, Ahmed M, Hays R, Ondo WG, Jaros MJ, Kim R, Shang G.

2015-11-149 citations

10.1016/j.sleep.2015.11.002

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.

Ondo WG, Hermanowicz N, Borreguero DG, Jaros MJ, Kim R, Shang G.

2015-03-301 citations

10.1186/s40734-015-0018-3

Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials.

Canafax DM, Bhanegaonkar A, Bharmal M, Calloway M.

2011-04-2810 citations

10.1186/1471-2377-11-48

Interventions

DRUGXP13512 (GSK1838262)

OTHERplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Onset of efficacy. Subjective measures of sleep.	12-week treatment period

Outcome results

None listed