A Multicenter, Double-blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Patients With Primary Generalized Tonic-Clonic Seizures

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

本研究旨在对比拉莫三嗪（lamotrigine）缓释片（LAMICTAL extended-release）与安慰剂治疗原发性全面性强直-阵挛发作（Primary Generalized Tonic-Clonic, PGTC）的有效性与安全性。拉莫三嗪缓释片属于试验性药物。安慰剂片剂外观与拉莫三嗪缓释片一致，但不含活性药物成分。本研究将在受试者现有癫痫治疗方案的基础上，加用拉莫三嗪缓释片或安慰剂片剂。