Pediatric Epilepsy Trial in Subjects 1-24 Months

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, South Brisbane, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lamotrigine

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2003
Study completion: 2003
First posted: Aug 15, 2002
Registry last updated: Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed