Proven seizure control with tolerability your pediatric patients need

In an 18-week, multicenter, double-blind, placebo-controlled trial in 199 patients 2 to 16 years of age

LAMICTAL demonstrated efficacy in pediatric patients inadequately controlled on existing therapy

Significantly greater median reduction in seizure frequency (Weeks 1–18)

Study design:
LAMICTAL or placebo was added to existing therapy of up to two AEDs over 6-week titration phase. Fixed doses (determined by weight and concomitant AED therapy) were continued over 12-week maintenance phase unless intolerance developed, in which case medication could be decreased to minimum maintenance dose and/or discontinued.

•	Safety and effectiveness of LAMICTAL have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate, or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs

Most Common Side Effects

Events occurring in >10% of patients in either treatment group

Adverse Event LAMICTAL (n=98) Placebo (n=101) Somnolence 24% 18% Vomiting 22% 19% Infection 21% 22% Dizziness 21% 5% Headache 18% 15% Rash* 16% 18% Fever 14% 12% Abdominal pain 13% 7% Tremor 12% 2% Nausea 11% 2% Rhinitis 14% 17% Accidental injury 14% 15% Diarrhea 13% 13% Pharyngitis 11% 10% Asthenia 11% 6% Ataxia 10% 2% Otitis media 9% 11% *Includes rash, erythema multiforme, maculopapular rash, urticaria, Stevens-Johnson syndrome, and vesiculobullous rash.

•	92% of patients taking LAMICTAL and 96% of patients taking placebo reported at least 1 adverse event
•	Approximately half of patients in each treatment group were receiving 1 versus 2 concomitant AEDs
•	Two patients taking LAMICTAL required hospitalization for rash; one on concomitant VPA was given an unconfirmed diagnosis of Stevens-Johnson syndrome. In both cases, all symptoms resolved when LAMICTAL was withdrawn

More than 5 million patient exposures worldwide and growing²

More than 13 years of worldwide postmarketing experience

Learn about pediatric dosing of LAMICTAL.