Research Article

Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome†‡§

  1. John W. Winkelman MD, PhD1,*,
  2. Richard K. Bogan MD2,
  3. Markus H. Schmidt MD, PhD3,
  4. John D. Hudson MD4,
  5. Sarah E. DeRossett MD, PhD5,
  6. Christina E. Hill-Zabala PharmD5

Article first published online: 24 MAY 2011

DOI: 10.1002/mds.23771

Issue

Movement Disorders

Movement Disorders

Volume 26, Issue 11, pages 2065–2072, September 2011

Additional Information

How to Cite

Winkelman, J. W., Bogan, R. K., Schmidt, M. H., Hudson, J. D., DeRossett, S. E. and Hill-Zabala, C. E. (2011), Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome. Mov. Disord., 26: 2065–2072. doi: 10.1002/mds.23771

Author Information

  1. 1

    Brigham and Women's Hospital Sleep Health Center, Brighton, Massachusetts, USA

  2. 2

    SleepMed, Columbia, South Carolina, USA

  3. 3

    Ohio Sleep Medicine Institute, Dublin, Ohio, USA

  4. 4

    FutureSearch Trials of Neurology, Austin, Texas, USA

  5. 5

    GlaxoSmithKline, Research Triangle Park, North Carolina, USA

*Brigham and Women's Hospital Sleep Health Center, 1505 Commonwealth Ave. 5th Floor, Brighton, MA 02135, USA

  1. †

    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.

  2. ‡

    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.

  3. §

    Full financial disclosures and author roles may be found in the online version of this article.

Publication History

  1. Issue published online: 19 SEP 2011
  2. Article first published online: 24 MAY 2011
  3. Manuscript Accepted: 4 APR 2011
  4. Manuscript Revised: 7 MAR 2011
  5. Manuscript Received: 24 NOV 2010

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Keywords:

  • gabapentin enacarbil;
  • polysomnography;
  • restless legs syndrome;
  • sleep disturbance

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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