Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome
We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enaca...
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| Published in | Movement disorders Vol. 26; no. 11; pp. 2065 - 2072 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Hoboken
Wiley Subscription Services, Inc., A Wiley Company
01.09.2011
Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0885-3185 1531-8257 1531-8257 |
| DOI | 10.1002/mds.23771 |
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| Abstract | We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome–associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. © 2011 Movement Disorder Society |
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| AbstractList | We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double-blind, placebo-controlled, 2-period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty-six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: -26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: -3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome-associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome.We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double-blind, placebo-controlled, 2-period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty-six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: -26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: -3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome-associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome–associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. © 2011 Movement Disorder Society We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double-blind, placebo-controlled, 2-period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty-six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: -26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: -3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome-associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. We assessed the efficacy and tolerability of gabapentin enacarbil in the treatment of moderate to severe primary restless legs syndrome and associated sleep disturbance. This was a multicenter, randomized, double‐blind, placebo‐controlled, 2‐period crossover polysomnography study of gabapentin enacarbil 1200 mg or placebo taken once daily. Subjects were randomized 1:1 to a sequence of gabapentin enacarbil:placebo or placebo:gabapentin enacarbil, receiving each treatment for 4 weeks. The primary end point was the mean change from baseline at weeks 4 and 10 (4/10) last observation carried forward in wake time during sleep. The key secondary end point was the mean change from baseline at weeks 4/10 last observation carried forward in periodic limb movements associated with arousal per hour of sleep. Tolerability assessments included adverse events. One hundred thirty‐six subjects were randomized (gabapentin enacarbil:placebo, 67; placebo:gabapentin enacarbil, 69), and 114 (gabapentin enacarbil:placebo, 53; placebo:gabapentin enacarbil, 61) completed the study. Gabapentin enacarbil 1200 mg significantly reduced wake time during sleep (mean change from baseline [adjusted mean treatment difference]: −26.0 minutes; P < .0001) and periodic limb movements associated with arousal per hour of sleep (adjusted mean treatment difference: −3.1 periodic limb movements with arousal/hour; P = .002) compared with placebo at weeks 4/10 last observation carried forward. The most commonly reported adverse events were dizziness (gabapentin enacarbil 20%, placebo 2%) and somnolence (gabapentin enacarbil 13%, placebo 2%). Gabapentin enacarbil 1200 mg once daily significantly reduces restless legs syndrome–associated sleep disturbance and periodic limb movements associated with arousal per hour of sleep and is generally well tolerated in adults with moderate to severe primary restless legs syndrome. © 2011 Movement Disorder Society |
| Author | Bogan, Richard K. Hudson, John D. Winkelman, John W. Schmidt, Markus H. Hill-Zabala, Christina E. DeRossett, Sarah E. |
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| Issue | 11 |
| Keywords | Human Sensitivity disorder Restless legs syndrome Nervous system diseases sleep disturbance Sleep disorder Neurological disorder Gabapentin enacarbil Polysomnography |
| Language | English |
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| Notes | istex:80D3C8FB34FFAA26DF8F1C26B314839720A5D8BC ark:/67375/WNG-K2P4B4TC-5 Full financial disclosures and author roles may be found in the online version of this article. ArticleID:MDS23771 Funding agencies: Research funding for design and conduct of this study and for collection, management, analysis, and interpretation of the data was sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina. Preparation and review of the manuscript were sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina. Relevant conflicts of interest/financial disclosures: Dr. John Winkelman has received consulting fees from GlaxoSmithKline. Dr. Richard Bogan has received consulting fees and research funding from GlaxoSmithKline and received research funding from XenoPort, Inc. Dr. Markus Schmidt has received consulting fees and research funding from GlaxoSmithKline and received research funding from Xenoport, Inc. Dr. John Hudson has served on the Speaker's Bureau for GlaxoSmithKline and received research funding from GlaxoSmithKline and XenoPort, Inc. Drs. DeRossett and Hill-Zabala are employees of GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Editorial assistance was provided by Sarah Brown and Phillippa Curran of Caudex Medical, Oxford, UK (funded by GlaxoSmithKline), who collated author comments. Assistance was provided with full consent of the authors and in compliance with Good Publication Practice 2 (BMJ 2009;339:b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the acknowledgments section of the manuscript. 2009;339:b4330 doi: 10.1136/b4330). The named authors meet the ICMJE criteria for authorship, and writing assistance is disclosed in the acknowledgments section of the manuscript. Research funding for design and conduct of this study and for collection, management, analysis, and interpretation of the data was sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina. Preparation and review of the manuscript were sponsored by GlaxoSmithKline, Research Triangle Park, North Carolina. Dr. John Winkelman has received consulting fees from GlaxoSmithKline. Dr. Richard Bogan has received consulting fees and research funding from GlaxoSmithKline and received research funding from XenoPort, Inc. Dr. Markus Schmidt has received consulting fees and research funding from GlaxoSmithKline and received research funding from Xenoport, Inc. Dr. John Hudson has served on the Speaker's Bureau for GlaxoSmithKline and received research funding from GlaxoSmithKline and XenoPort, Inc. Drs. DeRossett and Hill‐Zabala are employees of GlaxoSmithKline. No ghostwriting took place during the development of this manuscript. Editorial assistance was provided by Sarah Brown and Phillippa Curran of Caudex Medical, Oxford, UK (funded by GlaxoSmithKline), who collated author comments. Assistance was provided with full consent of the authors and in compliance with Good Publication Practice 2 Relevant conflicts of interest/financial disclosures Funding agencies BMJ ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 |
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A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: polysomnographic evaluation of periodic leg movements and sleep disturbance. Sleep Med 2009; 10: 630-636. Kushida CA, Walters AS, Becker P, et al. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep 2009; 32: 159-168. Montplaisir J, Nicolas A, Denesle R, Gomez-Mancilla B. Restless legs syndrome improved by pramipexole: a double-blind randomized trial. Neurology 1999; 52: 938-943. Rechtschaffen A, Kales A. A manual of standardized terminology, techniques and scoring system for sleep stages of human subjects. Washington, DC: US Government Printing Office, US Public Health Service; 1968. Trenkwalder C, Hening WA, Montagna P, et al. Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice. Mov Disord 2008; 23: 2267-2302. Montplaisir J, Boucher S, Poirier G, Lavigne G, Lapierre O, Lesperance P. Clinical, polysomnographic, and genetic characteristics of restless legs syndrome: a study of 133 patients diagnosed with new standard criteria. Mov Disord 1997; 12: 61-65. Calloway MO, Bharmal A, Hill-Zabala CE, Allen RP. Development and validation of a Subjective Post Sleep Diary (SPSD) to assess sleep status in subjects with restless legs syndrome. Sleep Med 2011; in press. Zucconi M, Ferri R, Allen R, et al. The official World Association of Sleep Medicine (WASM) standards for recording and scoring periodic leg movements in sleep (PLMS) and wakefulness (PLMW) developed in collaboration with a task force from the International Restless Legs Syndrome Study Group (IRLSSG). Sleep Med 2006; 7: 175-183. Partinen M, Hirvonen K, Jama L, et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study-the PRELUDE study. Sleep Med 2006; 7: 407-417. Cundy KC, Annamalai T, Bu L, et al. XP13512 [(±)-1-([(alpha-isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: II. Improved oral bioavailability, dose proportionality, and colonic absorption compared with gabapentin in rats and monkeys. J Pharmacol Exp Ther 2004; 311: 324-333. Garcia-Borreguero D, Larrosa O, de la Llave Y, Verger K, Masramon X, Hernandez G. Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study. Neurology 2002; 59: 1573-1579. Hening W, Walters AS, Allen RP, Montplaisir J, Myers A, Ferini-Strambi L. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. 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| References_xml | – reference: Goodglass H, Kaplan E. Assessment of Aphasia and Related Disorders. Philadelphia: Lea & Febiger; 1972. – reference: Hening W, Walters AS, Allen RP, Montplaisir J, Myers A, Ferini-Strambi L. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med 2004; 5: 237-246. – reference: Montplaisir J, Nicolas A, Denesle R, Gomez-Mancilla B. Restless legs syndrome improved by pramipexole: a double-blind randomized trial. Neurology 1999; 52: 938-943. – reference: Jama L, Hirvonen K, Partinen M, et al. A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: polysomnographic evaluation of periodic leg movements and sleep disturbance. Sleep Med 2009; 10: 630-636. – reference: Trenkwalder C, Hening WA, Montagna P, et al. Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice. Mov Disord 2008; 23: 2267-2302. – reference: Winkelman JW, Finn L, Young T. Prevalence and correlates of restless legs syndrome symptoms in the Wisconsin Sleep Cohort. Sleep Med 2006; 7: 545-552. – reference: Montplaisir J, Boucher S, Poirier G, Lavigne G, Lapierre O, Lesperance P. Clinical, polysomnographic, and genetic characteristics of restless legs syndrome: a study of 133 patients diagnosed with new standard criteria. Mov Disord 1997; 12: 61-65. – reference: Iber C, Ancoli-Israel S, Chesson A, Quan SF. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications. Westchester, IL: American Academy of Sleep Medicine; 2007. – reference: Zucconi M, Ferri R, Allen R, et al. The official World Association of Sleep Medicine (WASM) standards for recording and scoring periodic leg movements in sleep (PLMS) and wakefulness (PLMW) developed in collaboration with a task force from the International Restless Legs Syndrome Study Group (IRLSSG). Sleep Med 2006; 7: 175-183. – reference: Calloway MO, Bharmal A, Hill-Zabala CE, Allen RP. Development and validation of a Subjective Post Sleep Diary (SPSD) to assess sleep status in subjects with restless legs syndrome. Sleep Med 2011; in press. – reference: Reitan, R. Validity of the trail-making test as an indicator of organic brain disease. Percept Mot Skills 1958; 8: 271-276. – reference: Allen RP, Walters AS, Montplaisir J, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165: 1286-1292. – reference: Saletu M, Anderer P, Saletu-Zyhlarz GM, et al. Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome. J Neural Transm 2010; 117: 463-473. – reference: Lal R, Sukbuntherng J, Luo W, et al. Pharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: a randomized-sequence, double-blind, placebo-controlled, crossover study in healthy volunteers. Clin Ther 2009; 31: 1776-1786. – reference: Kushida CA, Walters AS, Becker P, et al. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep 2009; 32: 159-168. – reference: Partinen M, Hirvonen K, Jama L, et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study-the PRELUDE study. Sleep Med 2006; 7: 407-417. – reference: Allen R, Becker PM, Bogan R, et al. Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome. Sleep 2004; 27: 907-914. – reference: Happe S, Sauter C, Klosch G, Saletu B, Zeitlhofer J. Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome. Neuropsychobiology 2003; 48: 82-86. – reference: Rosen WG. Verbal fluency in aging and dementia. J Clin Neuropsychol 1980; 2: 135-146. – reference: Cundy KC, Annamalai T, Bu L, et al. XP13512 [(±)-1-([(alpha-isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: II. Improved oral bioavailability, dose proportionality, and colonic absorption compared with gabapentin in rats and monkeys. J Pharmacol Exp Ther 2004; 311: 324-333. – reference: Walters AS, Ondo WG, Kushida CA, et al. Gabapentin enacarbil in restless legs syndrome: A phase 2b, two-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol 2009; 32: 311-320. – reference: Hening WA, Allen RP. Restless legs syndrome (RLS): the continuing development of diagnostic standards and severity measures. Sleep Med 2003; 4: 95-97. – reference: Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisir J. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med 2003; 4: 101-119. – reference: Hornyak M, Kopasz M, Berger M, Riemann D, Voderholzer U. Impact of sleep-related complaints on depressive symptoms in patients with restless legs syndrome. J Clin Psychiatry 2005; 66: 1139-1145. – reference: Rechtschaffen A, Kales A. A manual of standardized terminology, techniques and scoring system for sleep stages of human subjects. Washington, DC: US Government Printing Office, US Public Health Service; 1968. – reference: Walters AS, Rye DB. Review of the relationship of restless legs syndrome and periodic limb movements in sleep to hypertension, heart disease, and stroke. Sleep 2009; 32: 589-597. – reference: Lahmeyer H, Wilcox CS, Kann J, Leppik I. Subjective efficacy of zolpidem in outpatients with chronic insomnia. A double-blind comparison with placebo. Clin Drug Investig 1997; 13: 134-144. – reference: Saletu M, Anderer P, Saletu B, et al. Sleep laboratory studies in restless legs syndrome patients as compared with normals and acute effects of ropinirole. 2. Findings on periodic leg movements, arousals and respiratory variables. Neuropsychobiology 2000; 41: 190-199. – reference: Saletu B, Gruber G, Saletu M, et al. Sleep laboratory studies in restless legs syndrome patients as compared with normals and acute effects of ropinirole. 1. Findings on objective and subjective sleep and awakening quality. Neuropsychobiology 2000; 41: 181-189. – reference: Bogan RK, Fry JM, Schmidt MH, Carson SW, Ritchie SY. Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial. Mayo Clin Proc 2006; 81: 17-27. – reference: Ferini-Strambi L, Aarskog D, Partinen M, et al. Effect of pramipexole on RLS symptoms and sleep: A randomized, double-blind, placebo-controlled trial. Sleep Med 2008; 9: 874-881. – reference: Cundy KC, Sastry S, Luo W, Zou J, Moors TL, Canafax DM. Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. J Clin Pharmacol 2008; 48: 1378-1388. – reference: Garcia-Borreguero D, Larrosa O, de la Llave Y, Verger K, Masramon X, Hernandez G. Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study. Neurology 2002; 59: 1573-1579. – reference: Cundy KC, Branch R, Chernov-Rogan T, et al. XP13512 [(±)-1-([(alpha-isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: I. Design, synthesis, enzymatic conversion to gabapentin, and transport by intestinal solute transporters. J Pharmacol Exp Ther 2004; 311: 315-323. – reference: Kushida CA, Becker PM, Ellenbogen AL, Canafax DM, Barrett RW, the XP, 052 Study Group. Randomized, double-blind, placebo-controlled trial of XP13512/GSK1838262 in patients with RLS. Neurology 2009; 72: 439-446. – reference: Atlas Task Force of The American Sleep Disorders Association. Recording and scoring leg movements. Sleep 1993; 16: 748-759. – start-page: 218 year: 1976 end-page: 222 – volume: 12 start-page: 61 year: 1997 end-page: 65 article-title: Clinical, polysomnographic, and genetic characteristics of restless legs syndrome: a study of 133 patients diagnosed with new standard criteria publication-title: Mov Disord – volume: 7 start-page: 407 year: 2006 end-page: 417 article-title: Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose‐finding study—the PRELUDE study publication-title: Sleep Med – year: 1968 – volume: 27 start-page: 907 year: 2004 end-page: 914 article-title: Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome publication-title: Sleep – year: 2007 – volume: 7 start-page: 175 year: 2006 end-page: 183 article-title: The official World Association of Sleep Medicine (WASM) standards for recording and scoring periodic leg movements in sleep (PLMS) and wakefulness (PLMW) developed in collaboration with a task force from the International Restless Legs Syndrome Study Group (IRLSSG) publication-title: Sleep Med – volume: 66 start-page: 1139 year: 2005 end-page: 1145 article-title: Impact of sleep‐related complaints on depressive symptoms in patients with restless legs syndrome publication-title: J Clin Psychiatry – volume: 23 start-page: 2267 year: 2008 end-page: 2302 article-title: Treatment of restless legs syndrome: an evidence‐based review and implications for clinical practice publication-title: Mov Disord – year: 2011 article-title: Development and validation of a Subjective Post Sleep Diary (SPSD) to assess sleep status in subjects with restless legs syndrome publication-title: Sleep Med – volume: 16 start-page: 748 year: 1993 end-page: 759 article-title: Recording and scoring leg movements publication-title: Sleep – volume: 41 start-page: 181 year: 2000 end-page: 189 article-title: Sleep laboratory studies in restless legs syndrome patients as compared with normals and acute effects of ropinirole. 1. Findings on objective and subjective sleep and awakening quality publication-title: Neuropsychobiology – volume: 9 start-page: 874 year: 2008 end-page: 881 article-title: Effect of pramipexole on RLS symptoms and sleep: A randomized, double‐blind, placebo‐controlled trial publication-title: Sleep Med – volume: 48 start-page: 1378 year: 2008 end-page: 1388 article-title: Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin publication-title: J Clin Pharmacol – volume: 10 start-page: 630 year: 2009 end-page: 636 article-title: A dose‐ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: polysomnographic evaluation of periodic leg movements and sleep disturbance publication-title: Sleep Med – volume: 81 start-page: 17 year: 2006 end-page: 27 article-title: Ropinirole in the treatment of patients with restless legs syndrome: a US‐based randomized, double‐blind, placebo‐controlled clinical trial publication-title: Mayo Clin Proc – volume: 32 start-page: 311 year: 2009 end-page: 320 article-title: Gabapentin enacarbil in restless legs syndrome: A phase 2b, two‐week, randomized, double‐blind, placebo‐controlled trial publication-title: Clin Neuropharmacol – volume: 8 start-page: 271 year: 1958 end-page: 276 article-title: Validity of the trail‐making test as an indicator of organic brain disease publication-title: Percept Mot Skills – volume: 48 start-page: 82 year: 2003 end-page: 86 article-title: Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome publication-title: Neuropsychobiology – volume: 52 start-page: 938 year: 1999 end-page: 943 article-title: Restless legs syndrome improved by pramipexole: a double‐blind randomized trial publication-title: Neurology – volume: 31 start-page: 1776 year: 2009 end-page: 1786 article-title: Pharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: a randomized‐sequence, double‐blind, placebo‐controlled, crossover study in healthy volunteers publication-title: Clin Ther – volume: 59 start-page: 1573 year: 2002 end-page: 1579 article-title: Treatment of restless legs syndrome with gabapentin: a double‐blind, cross‐over study publication-title: Neurology – volume: 72 start-page: 439 year: 2009 end-page: 446 article-title: Randomized, double‐blind, placebo‐controlled trial of XP13512/GSK1838262 in patients with RLS publication-title: Neurology – volume: 5 start-page: 237 year: 2004 end-page: 246 article-title: Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study publication-title: Sleep Med – volume: 32 start-page: 159 year: 2009 end-page: 168 article-title: A randomized, double‐blind, placebo‐controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome publication-title: Sleep – year: 1972 – volume: 117 start-page: 463 year: 2010 end-page: 473 article-title: Comparative placebo‐controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome publication-title: J Neural Transm – volume: 7 start-page: 545 year: 2006 end-page: 552 article-title: Prevalence and correlates of restless legs syndrome symptoms in the Wisconsin Sleep Cohort publication-title: Sleep Med – volume: 2 start-page: 135 year: 1980 end-page: 146 article-title: Verbal fluency in aging and dementia publication-title: J Clin Neuropsychol – start-page: 265 year: 1982 end-page: 295 – volume: 4 start-page: 95 year: 2003 end-page: 97 article-title: Restless legs syndrome (RLS): the continuing development of diagnostic standards and severity measures publication-title: Sleep Med – volume: 32 start-page: 589 year: 2009 end-page: 597 article-title: Review of the relationship of restless legs syndrome and periodic limb movements in sleep to hypertension, heart disease, and stroke publication-title: Sleep – volume: 4 start-page: 101 year: 2003 end-page: 119 article-title: Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health publication-title: Sleep Med – volume: 13 start-page: 134 year: 1997 end-page: 144 article-title: Subjective efficacy of zolpidem in outpatients with chronic insomnia. A double‐blind comparison with placebo publication-title: Clin Drug Investig – volume: 165 start-page: 1286 year: 2005 end-page: 1292 article-title: Restless legs syndrome prevalence and impact: REST general population study publication-title: Arch Intern Med – volume: 311 start-page: 324 year: 2004 end-page: 333 article-title: XP13512 [(±)‐1‐([(alpha‐isobutanoyloxyethoxy)carbonyl] aminomethyl)‐1‐cyclohexane acetic acid], a novel gabapentin prodrug: II. Improved oral bioavailability, dose proportionality, and colonic absorption compared with gabapentin in rats and monkeys publication-title: J Pharmacol Exp Ther – volume: 311 start-page: 315 year: 2004 end-page: 323 article-title: XP13512 [(±)‐1‐([(alpha‐isobutanoyloxyethoxy)carbonyl] aminomethyl)‐1‐cyclohexane acetic acid], a novel gabapentin prodrug: I. Design, synthesis, enzymatic conversion to gabapentin, and transport by intestinal solute transporters publication-title: J Pharmacol Exp Ther – volume: 41 start-page: 190 year: 2000 end-page: 199 article-title: Sleep laboratory studies in restless legs syndrome patients as compared with normals and acute effects of ropinirole. 2. 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| SubjectTerms | Adolescent Adult Aged Biological and medical sciences Carbamates - therapeutic use Child clinical studies Cross-Over Studies Developmental disorders Dose-Response Relationship, Drug Double-Blind Method Female gabapentin enacarbil gamma-Aminobutyric Acid - analogs & derivatives gamma-Aminobutyric Acid - therapeutic use Humans Infantile autism Male Medical sciences Middle Aged Neurology Polysomnography Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry restless legs syndrome Restless Legs Syndrome - drug therapy sleep disturbance Treatment Outcome Young Adult |
| Title | Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome |
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