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Assessment of the effects of lacosamide on sleep parameters in healthy subjects.

Publication ,  Journal Article
Hudson, JD; Guptill, JT; Byrnes, W; Yates, SL; Williams, P; D'Cruz, O
Published in: Seizure
February 2015

PURPOSE: Seizures and antiepileptic drugs (AED) may disrupt sleep patterns in patients with epilepsy, thus evaluation of lacosamide effects on objective and subjective sleep measures is warranted. METHODS: A multicenter, interventional, open-label study (NCT01530386) was conducted in healthy subjects without confounding effects of concomitant AED use, co-morbidities, or disease state to determine whether lacosamide impacts sleep parameters after 22 days of lacosamide exposure. After overnight polysomnography (PSG) to assess baseline parameters, lacosamide was initiated at 100mg/day (50mg twice daily) and increased by 100mg/day weekly to 300 mg/day (the mid-range maintenance dose for adjunctive therapy). The primary variable was change from baseline to post-treatment in wake after sleep onset (WASO). Secondary variables included additional objective sleep measures, subject-reported measures of sleep quality, daytime sleepiness, and tolerability. Change from baseline in WASO was analyzed using the Wilcoxon rank-sum test. RESULTS: A total of 27 subjects received ≥1 dose of lacosamide and 25 subjects completed the study. For WASO, median change from baseline was a 6-min reduction (95% confidence interval: -38, 77.5; p=0.1074) after lacosamide treatment; this was considered not clinically relevant. No clinically relevant changes were observed in any secondary variables. Thirteen subjects (48%) reported a treatment-emergent adverse event, none of which was severe or led to study discontinuation. CONCLUSION: Lacosamide 300 mg/day had no effect on objective or subjective sleep parameters in healthy subjects and was generally well tolerated.

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Published In

Seizure

DOI

EISSN

1532-2688

Publication Date

February 2015

Volume

25

Start / End Page

155 / 159

Location

England

Related Subject Headings

  • Young Adult
  • Sleep
  • Polysomnography
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Lacosamide
  • Humans
  • Female
  • Anticonvulsants
 

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Hudson, J. D., Guptill, J. T., Byrnes, W., Yates, S. L., Williams, P., & D’Cruz, O. (2015). Assessment of the effects of lacosamide on sleep parameters in healthy subjects. Seizure, 25, 155–159. https://doi.org/10.1016/j.seizure.2014.10.012
Hudson, J Douglas, Jeffrey T. Guptill, William Byrnes, Stephen L. Yates, Paulette Williams, and O’Neill D’Cruz. “Assessment of the effects of lacosamide on sleep parameters in healthy subjects.Seizure 25 (February 2015): 155–59. https://doi.org/10.1016/j.seizure.2014.10.012.
Hudson JD, Guptill JT, Byrnes W, Yates SL, Williams P, D’Cruz O. Assessment of the effects of lacosamide on sleep parameters in healthy subjects. Seizure. 2015 Feb;25:155–9.
Hudson, J. Douglas, et al. “Assessment of the effects of lacosamide on sleep parameters in healthy subjects.Seizure, vol. 25, Feb. 2015, pp. 155–59. Pubmed, doi:10.1016/j.seizure.2014.10.012.
Hudson JD, Guptill JT, Byrnes W, Yates SL, Williams P, D’Cruz O. Assessment of the effects of lacosamide on sleep parameters in healthy subjects. Seizure. 2015 Feb;25:155–159.
Journal cover image

Published In

Seizure

DOI

EISSN

1532-2688

Publication Date

February 2015

Volume

25

Start / End Page

155 / 159

Location

England

Related Subject Headings

  • Young Adult
  • Sleep
  • Polysomnography
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Lacosamide
  • Humans
  • Female
  • Anticonvulsants