Skip to main content

Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months.

Publication ,  Journal Article
Piña-Garza, JE; Levisohn, P; Gucuyener, K; Mikati, MA; Warnock, CR; Conklin, HS; Messenheimer, J
Published in: Neurology
May 27, 2008

OBJECTIVE: This randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy and tolerability of adjunctive lamotrigine for the treatment of partial seizures in infants aged 1 to 24 months. METHODS: The study used a responder-enriched design in which all patients received adjunctive lamotrigine during an open-label phase (n = 177; maximum maintenance dose 5.1 mg/kg/day for those on non-enzyme-inducing antiepileptic drugs [AEDs] or valproate and 15.6 mg/kg/day for those on enzyme-inducing AEDs). Patients meeting response criteria were randomly assigned to double-blind treatment for up to 8 weeks with continued lamotrigine (n = 19) or to withdrawal from lamotrigine (placebo; n = 19) while background AEDs were maintained. RESULTS: The proportion of treatment failures (patients who met escape criteria or withdrew before completing the double-blind phase) was lower with lamotrigine (58%) than with placebo (84%). This finding was not significant in the primary analysis (two-sided chi(2) test [primary endpoint]). A post hoc sensitivity analysis of the primary endpoint was also performed (p = 0.045 by one-sided, mid-p corrected Fisher exact test). The median time to meet escape criteria was longer with lamotrigine (42 days) than with placebo (22 days) (p = 0.059). During the last 28 days of the open-label phase, 53% of the patients had a >or=50% reduction in frequency of partial seizures with lamotrigine. Additional reduction in partial seizure frequency was observed during the double-blind phase compared with the last 4 weeks of the open-label phase among those randomly assigned to lamotrigine (32% with a >or=25% reduction) but not those randomly assigned to placebo (5% with a >or=25% reduction). Lamotrigine was well tolerated, with an adverse event profile comparable to that observed in older pediatric patients. CONCLUSION: Lamotrigine was well tolerated, and the data indicate that it may be efficacious in the treatment of partial seizures in infants aged 1 to 24 months.

Duke Scholars

Published In

Neurology

DOI

EISSN

1526-632X

Publication Date

May 27, 2008

Volume

70

Issue

22 Pt 2

Start / End Page

2099 / 2108

Location

United States

Related Subject Headings

  • Valproic Acid
  • Triazines
  • Treatment Outcome
  • Neurology & Neurosurgery
  • Male
  • Lamotrigine
  • Infant
  • Humans
  • Female
  • Epilepsies, Partial
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Piña-Garza, J. E., Levisohn, P., Gucuyener, K., Mikati, M. A., Warnock, C. R., Conklin, H. S., & Messenheimer, J. (2008). Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months. Neurology, 70(22 Pt 2), 2099–2108. https://doi.org/10.1212/01.wnl.0000285493.08622.35
Piña-Garza, J. E., P. Levisohn, K. Gucuyener, M. A. Mikati, C. R. Warnock, H. S. Conklin, and J. Messenheimer. “Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months.Neurology 70, no. 22 Pt 2 (May 27, 2008): 2099–2108. https://doi.org/10.1212/01.wnl.0000285493.08622.35.
Piña-Garza JE, Levisohn P, Gucuyener K, Mikati MA, Warnock CR, Conklin HS, et al. Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months. Neurology. 2008 May 27;70(22 Pt 2):2099–108.
Piña-Garza, J. E., et al. “Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months.Neurology, vol. 70, no. 22 Pt 2, May 2008, pp. 2099–108. Pubmed, doi:10.1212/01.wnl.0000285493.08622.35.
Piña-Garza JE, Levisohn P, Gucuyener K, Mikati MA, Warnock CR, Conklin HS, Messenheimer J. Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months. Neurology. 2008 May 27;70(22 Pt 2):2099–2108.

Published In

Neurology

DOI

EISSN

1526-632X

Publication Date

May 27, 2008

Volume

70

Issue

22 Pt 2

Start / End Page

2099 / 2108

Location

United States

Related Subject Headings

  • Valproic Acid
  • Triazines
  • Treatment Outcome
  • Neurology & Neurosurgery
  • Male
  • Lamotrigine
  • Infant
  • Humans
  • Female
  • Epilepsies, Partial