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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects Wtih Primary Generalized Tonic-Clonic Seizures

Brief 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: % change from Baseline in average monthly PGTC seizure frequency

Original Primary Outcome:

Current Secondary Outcome: Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency.

Original Secondary Outcome:

Information By: GlaxoSmithKline

Dates:
Date Received: August 14, 2002
Date Started: December 1, 2000
Date Completion:
Last Updated: March 31, 2017
Last Verified: March 2017