drugset / Trial / NCT00104416

Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures

NCT00104416

Phase 3 Completed 153 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2004-12
Primary completion
2008-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lamotrigine Small molecule