Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug

Summary

The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.

Timeline

Start

2000-12-01

Primary completion

2003-11-01

Completion

2005-03-01

Outcome

Met primary endpoint

paper median percent reduction in PGTC seizure frequency was 66.5% with lamotrigine compared with 34.2% with placebo (p = 0.006). PMID 16344515 ↗

Publications

• Results Biton V, Sackellares JC, Vuong A, Hammer AE, Barrett PS, Messenheimer JA. Double-blind, placebo-controlled study of lamotrigine in primary generalized tonic-clonic seizures. Neurology. 2005 Dec 13;65(11):1737-43. doi: 10.1212/01.wnl.0000187118.19221.e4.

Drugs

Indications