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Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures

From Arkansas Epilepsy Program (Dr. Biton), Little Rock; University of Florida and Malcolm Randall VA Medical Center (Dr. Sackellares), Gainesville; and GlaxoSmithKline (A. Vuong, A.E. Hammer, and Drs. Barrett and Messenheimer), Research Triangle Park, NC.

Address correspondence and reprint requests to Dr. Victor Biton, Arkansas Epilepsy Program, Two Lile Court, Suite 100, Little Rock, AR 72205; e-mail: vbiton{at}alltel.net

Objective: To evaluate the efficacy and tolerability of adjunctive lamotrigine in primary generalized tonic-clonic (PGTC) seizures in a randomized, double-blind, placebo-controlled trial.

Methods: Patients with a diagnosis of epilepsy with PGTC seizures who were receiving one or two antiepileptic drugs at study entry were eligible. Patients with partial seizures were excluded on the basis of seizure history and screening EEGs. The study comprised a baseline phase, an escalation phase during which study medication was titrated to a target dose, and a 12-week maintenance phase during which doses of lamotrigine/placebo and concomitant antiepileptic drugs were maintained.

Results: Of the 121 randomized patients ages 2 to 55 years, 117 (58 lamotrigine, 59 placebo) entered the escalation phase and received study medication. During the escalation and maintenance phases combined, median percent reduction in PGTC seizure frequency was 66.5% with lamotrigine compared with 34.2% with placebo (p = 0.006). The corresponding numbers for lamotrigine and placebo were 60.6% and 32.8% (p = 0.038) during the escalation phase and 81.9% and 43.0% (p = 0.006) during the maintenance phase. During the maintenance phase, 72% of lamotrigine-treated patients compared with 49% of placebo-treated patients experienced a 50% reduction in frequency of PGTC seizures (p = 0.014). A similar pattern of results was observed for all generalized seizures. The most common drug-related adverse events were dizziness (5% lamotrigine, 2% placebo), somnolence (5% lamotrigine, 2% placebo), and nausea (5% lamotrigine, 3% placebo).

Conclusions: Adjunctive lamotrigine is effective in the treatment of primary generalized tonic-clonic seizures and has a favorable tolerability profile.

Funded by GlaxoSmithKline, manufacturer of lamotrigine.

Presented at the 2005 annual meeting of the American Academy of Neurology.

Disclosure: A. Vuong, A.E. Hammer, P.S. Barrett, PharmD, and J.A. Messenheimer, MD, are employees of GlaxoSmithKline. V. Biton, MD, and J.C. Sackellares, MD, have been clinical investigators participating in GlaxoSmithKline-sponsored clinical trials (including the one described in this article).

Received March 16, 2005. Accepted in final form August 22, 2005.

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