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

Tracking Information

First Received Date ^ICMJE

August 23, 2002

Last Updated Date

May 15, 2009

Start Date ^ICMJE

September 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The long-term safety of LAMICTAL will be assessed by adverse events, ECGs, vital signs,and laboratory tests. [ Time Frame: 43 Months ]

Original Primary Outcome Measures ^ICMJE

The long-term safety of LAMICTAL will be assessed by adverse events, ECGs, vital signs,and laboratory tests.

Change History

Complete list of historical versions of study NCT00044278 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effectiveness will be assessed by percent change from baseline in seizure frequency over the course of treatment. Investigators global evaluation of subjects status; standard pharmacokinetics. [ Time Frame: 43 Months ]

Original Secondary Outcome Measures ^ICMJE

Effectiveness will be assessed by percent change from baseline in seizure frequency over the course of treatment. Investigators' global evaluation of subjects' status; standard pharmacokinetics.

Descriptive Information

Brief Title ^ICMJE

Pediatric Epilepsy Study in Subjects 1-24 Months

Official Title ^ICMJE

An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-Naive Subjects (1-24 Months of Age)

Brief Summary

This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group 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

225

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
A confident diagnosis of epilepsy.
4 or more partial seizures per month.
current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria:

Has seizures not related to epilepsy.
Has a surgically implanted and functioning vagal nerve stimulator.
Has previously been treated with lamotrigine.
Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.
Use of experimental medication within 30 days of enrollment.

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, Argentina, Australia, Estonia, France, Hungary, Italy, Latvia, Lebanon, Lithuania, Netherlands, Portugal, Puerto Rico, Slovakia, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00044278

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LAM20007

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