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