Abstract
We conducted a single-blind, controlled comparative study to assess the effects of lamotrigine (LTG) and zonisamide (ZNS) in the treatment of refractory epilepsy in children. Either LTG or ZNS was added to a concurrent antiepileptic regimen for 12 weeks. Efficacy and usefulness were analyzed in 168 patients and safety was analyzed in 169. As the primary end points of over-all improvement LTG showed non-inferiority effect to ZNS in improvement rate and its distribution. In the Over-50% seizure reduction rate of Lennox-Gastaut syndrome, LTG was significantly superior to ZNS (39% to 13%, p=0.0219). The incidence of adverse events was 43% in LTG group and 54% in ZNS group, and the most common side effect was somnolence in both groups. Two patents in LTG group experienced serious adverse events suspected causal relationship with trial drugs. One was Stevens-Johnson syndrome and another was exacerbation of seizures. There was no significant difference in the safety rate between groups. LTG was significantly superior to ZNS in the global usefulness scale (p=0.0287). These results indicate the significance of LTG in the treatment of intractable childhood epilepsy including LGS.
