Clinical Trials Directory

Trials / Completed

CompletedNCT00355082

Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy

A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
226 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
13 Years
Healthy volunteers
Not accepted

Summary

This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.

Detailed description

The study consists of a Treatment phase, where efficacy is determined and a Continuation phase for extended safety information. The Continuation phase is open to all Treatment phase participants and those who did not qualify for treatment because of an insufficient number of seizures during the Baseline phase.

Conditions

Interventions

TypeNameDescription
DRUGlamotrigine, 300 mg/day300 mg/day
DRUGlamotrigine, 250 mg/day250 mg/day

Timeline

Start date
2006-05-01
Primary completion
2008-11-01
Completion
2008-11-01
First posted
2006-07-21
Last updated
2017-01-02
Results posted
2009-11-25

Locations

103 sites across 8 countries: United States, Argentina, Chile, Costa Rica, Puerto Rico, Russia, South Korea, Ukraine

Source: ClinicalTrials.gov record NCT00355082. Inclusion in this directory is not an endorsement.