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Title: Adjunctive Lamotrigine Decreases Primary Generalized Tonic-Clonic Seizures: Presented at AES

"Adjunctive Lamotrigine Decreases Primary Generalized Tonic-Clonic Seizures: Presented at AES"

By Fran Lowry WASHINGTON, DC -- December 9, 2005 -- Adjunctive lamotrigine effectively controls primary generalized tonic-clonic seizures (PGTCS) and is well-tolerated in adults and pediatric patients 2 years and older, according to results of a randomized, double-blind, placebo-controlled study. "The median percent decrease in PGTC seizures became statistically significant after 5 weeks of treatment in the overall population, and after 3 weeks of treatment in patients > 12 years of age," said Victor Biton, MD, Arkansas Epilepsy Program, Little Rock, Arkansas, United States, in a presentation here at the 59[^th Annual Meeting of the American Epilepsy Society (AES).

"The data from this study -- which excluded patients with partial seizures -- add to previous findings demonstrating the broad clinical utility of lamotrigine," Dr. Biton noted.

His team assessed the efficacy, time to onset, and tolerability of lamotrigine in lamotrigine-naïve patients older than 2 years and weighing 13 kg or more. Subjects had at least three PGTCS over an 8-week period on one or two antiepileptic drugs (AEDs) and evidence of generalized epileptiform discharges or no evidence of interictal expression of partial seizures.

Subjects were randomized to lamotrigine or placebo in an escalation treatment phase that lasted 12 weeks for patients 2 to 12 years old and 7 weeks for patients older than 12 years. All patients also underwent a 12-week maintenance phase.

The most commonly used antiepileptic agents were valproate, phenytoin, and topiramate, followed by carbamazepine and phenobarbital.

Overall, patients randomized to lamotrigine had a median 56% decrease in PGTCS after 5 weeks compared to a 30% decrease in placebo patients (P = .036). In patients who were older than 12 years, the decreases after 3 weeks were 63% and 33%, respectively (P = .045).

For the entire treatment period, patients randomized to lamotrigine had a median decrease in PGTCS of 66% compared to 34% for the placebo group (P = .006), Dr. Biton reported.

The most common drug-related adverse events were dizziness (5% for lamotrigine; 2% for placebo), somnolence (5% and 2%), nausea (5% and 2%). The rate of non-serious rash was 3% in both groups. No serious rash was reported.

"We purposely excluded patients with partial seizures so that we could rigorously assess lamotrigine's efficacy and safety profile in PGTC seizures," Dr. Biton said.

"Our results from this study clearly demonstrate that lamotrigine is a broad spectrum antiepileptic drug which is efficacious and well tolerated in patients with generalized seizures," he concluded.

[Presentation title: Onset of Efficacy with Lamotrigine in Primary Generalized Tonic-Clonic Seizures (PGTCS): A Randomized, Placebo-Controlled Study. Abstract 2.455]

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