Pediatric Epilepsy Trial in Subjects 1-24 Months - Tabular View

Tracking Information

First Received Date ^ICMJE

August 14, 2002

Last Updated Date

May 15, 2009

Start Date ^ICMJE

May 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase. [ Time Frame: 36 Months ]

Original Primary Outcome Measures ^ICMJE

The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.

Change History

Complete list of historical versions of study NCT00043875 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events [ Time Frame: 36 Months ]

Original Secondary Outcome Measures ^ICMJE

Time to escape patterns in Double-Blind phase.
Reduction in partial seizure frequency at end of Open-Label Phase.
Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases.
Standard pharmacokinetics
Adverse Events

Descriptive Information

Brief Title ^ICMJE

Pediatric Epilepsy Trial in Subjects 1-24 Months

Official Title ^ICMJE

A Double-Blind, Placebo-Controlled, Add-on Clinical Trial of the Safety, Pharmacokinetics and Efficacy of LAMICTAL in Pediatric Age Subjects (1-24 Months)

Brief Summary

This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: lamotrigine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

INCLUSION CRITERIA:

Have a confident diagnosis of epilepsy
Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs (EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing antiepileptic drugs (non-EIADs)
Have no underlying chronic metabolism problems
Have normal lab results
Have a normal electrocardiogram (ECG)

EXCLUSION CRITERIA:

Have a diagnosis of severe, progressive myoclonus.
Have seizures not related to epilepsy.
Have previously demonstrated sensitivity or allergic reaction to the study drug or its related compounds.
Have progressive or unstable condition of the nervous system.
Used experimental medication within 30 of enrollment into the study.
Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI) condition.
Current use of the medication felbamate.
Current use of adrenocorticotrophic hormone (ACTH).
Following a ketogenic diet.
Receiving vagal nerve stimulation (VNS).

Gender

Both

Ages

1 Month to 24 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Estonia, France, Hungary, Italy, Latvia, Lebanon, Lithuania, Netherlands, Portugal, Slovakia, Spain, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00043875

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LAM20006

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP