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

Mansoor Ahmed, Ryan Hays, J. Steven Poceta, Mark J. Jaros, Richard Kim, Gwendoline Shang

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Purpose: Few studies have investigated restless legs syndrome (RLS) treatment effects on individual International RLS Study Group Rating Scale (IRLS) items. We assessed the effects of gabapentin enacarbil (GEn) on individual IRLS items and their correlation with sleep disturbances in adults with moderate-to-severe primary RLS. Methods: Data were pooled from the randomized, double-blind, placebo-controlled, 12-week studies of XP052, XP053, and XP081 for adults who received GEn (600 or 1200 mg) or placebo once daily. Adults had primary RLS, IRLS total score ≥15, and RLS symptoms >15 days during the month before screening and for ≥4 of the 7 consecutive evenings at baseline. End points included mean change from baseline to week 12 in individual IRLS and post-sleep questionnaire (PSQ) items. For IRLS items, least squares mean treatment differences were calculated from a mixed model for repeated measures. For PSQ items, Cochran-Mantel-Haenszel row mean scores tests with integer scoring were used. Correlations between IRLS and PSQ items were assessed by Spearman's rank coefficients. Safety profile outcomes included treatment-emergent adverse events (TEAEs) and serious TEAEs. Findings: The modified intent-to-treat population included 671 patients (GEn 600 mg = 161; GEn 1200 mg = 266; placebo = 244). GEn significantly improved mean [SE] differences versus placebo for all IRLS items at week 12, including severity of sleep disturbance (GEn 600 mg, -0.4 [0.10]; GEn 1200 mg, -0.4 [0.09]), daytime tiredness (-0.4 [0.09]; -0.4 [0.08]), RLS severity (-0.4 [0.10]; -0.3 [0.08]), impact on daily affairs (-0.3 [0.07]; -0.3 [0.07]), and mood disturbance (-0.2 [0.07]; -0.3 [0.06]); all P

Original languageEnglish (US)
JournalClinical Therapeutics
DOIs
StateAccepted/In press - 2016

Fingerprint

Restless Legs Syndrome
Sleep
Placebos
Surveys and Questionnaires
1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid
Least-Squares Analysis
Therapeutics
Safety
Population

Keywords

  • Gabapentin enacarbil
  • International Restless Legs Study Group Rating Scale
  • Post-sleep questionnaire
  • Restless legs syndrome
  • Sleep

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

@article{eabc206f45f845beb73c13df31f717f2,
title = "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",
abstract = "Purpose: Few studies have investigated restless legs syndrome (RLS) treatment effects on individual International RLS Study Group Rating Scale (IRLS) items. We assessed the effects of gabapentin enacarbil (GEn) on individual IRLS items and their correlation with sleep disturbances in adults with moderate-to-severe primary RLS. Methods: Data were pooled from the randomized, double-blind, placebo-controlled, 12-week studies of XP052, XP053, and XP081 for adults who received GEn (600 or 1200 mg) or placebo once daily. Adults had primary RLS, IRLS total score ≥15, and RLS symptoms >15 days during the month before screening and for ≥4 of the 7 consecutive evenings at baseline. End points included mean change from baseline to week 12 in individual IRLS and post-sleep questionnaire (PSQ) items. For IRLS items, least squares mean treatment differences were calculated from a mixed model for repeated measures. For PSQ items, Cochran-Mantel-Haenszel row mean scores tests with integer scoring were used. Correlations between IRLS and PSQ items were assessed by Spearman's rank coefficients. Safety profile outcomes included treatment-emergent adverse events (TEAEs) and serious TEAEs. Findings: The modified intent-to-treat population included 671 patients (GEn 600 mg = 161; GEn 1200 mg = 266; placebo = 244). GEn significantly improved mean [SE] differences versus placebo for all IRLS items at week 12, including severity of sleep disturbance (GEn 600 mg, -0.4 [0.10]; GEn 1200 mg, -0.4 [0.09]), daytime tiredness (-0.4 [0.09]; -0.4 [0.08]), RLS severity (-0.4 [0.10]; -0.3 [0.08]), impact on daily affairs (-0.3 [0.07]; -0.3 [0.07]), and mood disturbance (-0.2 [0.07]; -0.3 [0.06]); all P",
keywords = "Gabapentin enacarbil, International Restless Legs Study Group Rating Scale, Post-sleep questionnaire, Restless legs syndrome, Sleep",
author = "Mansoor Ahmed and Ryan Hays and {Steven Poceta}, J. and Jaros, {Mark J.} and Richard Kim and Gwendoline Shang",
year = "2016",
doi = "10.1016/j.clinthera.2016.05.008",
language = "English (US)",
journal = "Clinical Therapeutics",
issn = "0149-2918",
publisher = "Excerpta Medica",

}

TY - JOUR

T1 - 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

T2 - Pooled Analysis of 3 Randomized Trials

AU - Ahmed, Mansoor

AU - Hays, Ryan

AU - Steven Poceta, J.

AU - Jaros, Mark J.

AU - Kim, Richard

AU - Shang, Gwendoline

PY - 2016

Y1 - 2016

N2 - Purpose: Few studies have investigated restless legs syndrome (RLS) treatment effects on individual International RLS Study Group Rating Scale (IRLS) items. We assessed the effects of gabapentin enacarbil (GEn) on individual IRLS items and their correlation with sleep disturbances in adults with moderate-to-severe primary RLS. Methods: Data were pooled from the randomized, double-blind, placebo-controlled, 12-week studies of XP052, XP053, and XP081 for adults who received GEn (600 or 1200 mg) or placebo once daily. Adults had primary RLS, IRLS total score ≥15, and RLS symptoms >15 days during the month before screening and for ≥4 of the 7 consecutive evenings at baseline. End points included mean change from baseline to week 12 in individual IRLS and post-sleep questionnaire (PSQ) items. For IRLS items, least squares mean treatment differences were calculated from a mixed model for repeated measures. For PSQ items, Cochran-Mantel-Haenszel row mean scores tests with integer scoring were used. Correlations between IRLS and PSQ items were assessed by Spearman's rank coefficients. Safety profile outcomes included treatment-emergent adverse events (TEAEs) and serious TEAEs. Findings: The modified intent-to-treat population included 671 patients (GEn 600 mg = 161; GEn 1200 mg = 266; placebo = 244). GEn significantly improved mean [SE] differences versus placebo for all IRLS items at week 12, including severity of sleep disturbance (GEn 600 mg, -0.4 [0.10]; GEn 1200 mg, -0.4 [0.09]), daytime tiredness (-0.4 [0.09]; -0.4 [0.08]), RLS severity (-0.4 [0.10]; -0.3 [0.08]), impact on daily affairs (-0.3 [0.07]; -0.3 [0.07]), and mood disturbance (-0.2 [0.07]; -0.3 [0.06]); all P

AB - Purpose: Few studies have investigated restless legs syndrome (RLS) treatment effects on individual International RLS Study Group Rating Scale (IRLS) items. We assessed the effects of gabapentin enacarbil (GEn) on individual IRLS items and their correlation with sleep disturbances in adults with moderate-to-severe primary RLS. Methods: Data were pooled from the randomized, double-blind, placebo-controlled, 12-week studies of XP052, XP053, and XP081 for adults who received GEn (600 or 1200 mg) or placebo once daily. Adults had primary RLS, IRLS total score ≥15, and RLS symptoms >15 days during the month before screening and for ≥4 of the 7 consecutive evenings at baseline. End points included mean change from baseline to week 12 in individual IRLS and post-sleep questionnaire (PSQ) items. For IRLS items, least squares mean treatment differences were calculated from a mixed model for repeated measures. For PSQ items, Cochran-Mantel-Haenszel row mean scores tests with integer scoring were used. Correlations between IRLS and PSQ items were assessed by Spearman's rank coefficients. Safety profile outcomes included treatment-emergent adverse events (TEAEs) and serious TEAEs. Findings: The modified intent-to-treat population included 671 patients (GEn 600 mg = 161; GEn 1200 mg = 266; placebo = 244). GEn significantly improved mean [SE] differences versus placebo for all IRLS items at week 12, including severity of sleep disturbance (GEn 600 mg, -0.4 [0.10]; GEn 1200 mg, -0.4 [0.09]), daytime tiredness (-0.4 [0.09]; -0.4 [0.08]), RLS severity (-0.4 [0.10]; -0.3 [0.08]), impact on daily affairs (-0.3 [0.07]; -0.3 [0.07]), and mood disturbance (-0.2 [0.07]; -0.3 [0.06]); all P

KW - Gabapentin enacarbil

KW - International Restless Legs Study Group Rating Scale

KW - Post-sleep questionnaire

KW - Restless legs syndrome

KW - Sleep

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U2 - 10.1016/j.clinthera.2016.05.008

DO - 10.1016/j.clinthera.2016.05.008

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JF - Clinical Therapeutics

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