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

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Hudson, JD; Guptill, JT; Byrnes, W; Yates, SL; Williams, P; D'Cruz, O

Published Date

  • February 2015

Published In

Volume / Issue

  • 25 /

Start / End Page

  • 155 - 159

PubMed ID

  • 25468512

Electronic International Standard Serial Number (EISSN)

  • 1532-2688

Digital Object Identifier (DOI)

  • 10.1016/j.seizure.2014.10.012


  • eng

Conference Location

  • England