Abstracts

This abstract reports long term efficacy and tolerability results from the Continuation Phase of a study with lamotrigine (LTG) as adjunctive therapy in patients with primary generalized tonic-clonic seizures (PGTCS)., LTG-na[iuml]ve patients ([ge] 2 years, [ge] 13 kg) with inadequately controlled PGTCS, receiving a regimen of 1 or 2 AED(s) and an electroencephalogram (EEG) with evidence of generalized epileptiform discharges or no evidence of interictal expression of partial seizures were enrolled in a randomized, double-blind, placebo-controlled trial (results presented at AES 2005). Patients having [ge] 3 PGTCS over an 8-week Baseline were randomized to receive LTG or placebo (PBO). Subjects, from either group, who completed the Blinded Phase, could enroll into a 1-year Continuation Phase (subjects on PBO converted to LTG)., 89 subjects entered the Continuation Phase. LTG group: n=42, 50% male, median age=27 years (n=9 for 2-12 years, n=33 for [gt] 12 years, range=2-53 years),50% with 1 concurrent AED, most common concurrent AEDs were valproate (n=19, 45%) and phenytoin (n=15, 36%) median PGTCS during Baseline=2.0. PBO group: n=47, 68% male, median age=23 years (n=9 for 2-12 years, n=38 for [gt] 12 years, range=2-58 years), 68% with 1 concurrent AED, most common concurrent AEDs were valproate (n=25, 53%) and phenytoin (n=9, 19%), median PGTCS during Baseline=2.7. The median percent decrease from Baseline in PGTCS was 90% and 84% during the Continuation Phase for subjects who received LTG and PBO in the Blinded Phase, respectively. For the LTG group, this decrease was similar to that observed in the Blinded Phase (82%). The median PGTCS counts per month were 2.0 and 2.7 during Baseline, and 0.2 and 0.1 during the Continuation Phase for the LTG and PBO groups, respectively. For the LTG group, the median PGTCS count per month was 0.8 in the Blinded Phase. Drug-related adverse events were 14% (LTG) and 19% (PBO)., The results from this study, combined with the efficacy and safety of LTG for partial seizures, demonstrate that LTG is a broad spectrum AED for patients with either partial or generalized seizures., (Supported by GlaxoSmithKline.)