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Pediatric Epilepsy Study in Subjects 1-24 Months | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Pediatric Epilepsy Study in Subjects 1-24 Months

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)

NCT00044278•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 2 years

Sex

ALL

Healthy Volunteers

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.

Locations (70)

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Stanford, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Jacksonville, Florida, United States

Key Dates

Start Date

September 1, 2000

Primary Completion Date

June 1, 2006

Completion Date

June 1, 2006

Last Updated

January 18, 2017

Enrollment

197

ACTUAL participants

Conditions

Epilepsy

Interventions

lamotrigine

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

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RECRUITINGPHASE1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

NCT02531880

Epilepsy

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pediatric Epilepsy Study in Subjects 1-24 Months

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

MEHMO Natural History and Biomarkers