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Pediatric Epilepsy Trial in Subjects 1-24 Months

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: lamotrigine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

The difference in the time to escape patterns between LAMICTAL and placebo

The proportion of subjects achieving a reduction in monthly partial seizure frequency from baseline between 40%-80% at the end of the Open-Label Phase

Percent change from baseline in seizure frequency at the end of the Open-Label Phase by seizure type

The investigators' global evaluation of the subjects' status at the end of the Open-Label and Double-Blind Phases

Pharmacokinetic parameter assessment - Maximum Plasma Concentration (Cmax)

The incidence of adverse events over the course of the study

The change from baseline in clinical laboratory and vital sign values

Pharmacokinetic parameter assessment - Area Under the Curve (AUC)

Pharmacokinetic parameter assessment - CL/F (Oral clearance)

Eligibility

Minimum age: 1 Month. Maximum age: 24 Months. Gender(s): Both.

Criteria:

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).

Locations and Contacts

GSK Investigational Site, Tartu 51014, Estonia

GSK Investigational Site, Riga LV 1004, Latvia

GSK Investigational Site, Beirut 11072020, Lebanon

GSK Investigational Site, Rotterdam 3015 GD, Netherlands

GSK Investigational Site, Las Palmas De Gran Canaria 35016, Spain

GSK Investigational Site, Ankara, Turkey

GSK Investigational Site, Tucson, Arizona 85712, United States

GSK Investigational Site, Little Rock, Arkansas 72202, United States

GSK Investigational Site, Los Angeles, California 90027, United States

GSK Investigational Site, Stanford, California 94305-5235, United States

GSK Investigational Site, Denver, Colorado 80218, United States

GSK Investigational Site, Washington, District of Columbia 20010, United States

GSK Investigational Site, Jacksonville, Florida 32207, United States

GSK Investigational Site, Miami, Florida 33155-3009, United States

GSK Investigational Site, Orlando, Florida 32835, United States

GSK Investigational Site, Tallahassee, Florida 32308, United States

GSK Investigational Site, Tampa, Florida 33607-6350, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Augusta, Georgia 30912, United States

GSK Investigational Site, Lexington, Kentucky 40536-0284, United States

GSK Investigational Site, St. Paul, Minnesota 55102-2383, United States

GSK Investigational Site, Kansas City, Missouri 64108, United States

GSK Investigational Site, Chapel Hill, North Carolina 27599, United States

GSK Investigational Site, Raleigh, North Carolina 27607, United States

GSK Investigational Site, Akron, Ohio 44308-1062, United States

GSK Investigational Site, Columbus, Ohio 43205, United States

GSK Investigational Site, Portland, Oregon 97227, United States

GSK Investigational Site, Portland, Oregon 97239, United States

GSK Investigational Site, Nashville, Tennessee 37212, United States

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, Fort Worth, Texas 76104, United States

GSK Investigational Site, Perth, Western Australia, Australia

Additional Information

Starting date: May 2000
Last updated: August 19, 2015

Page last updated: August 23, 2015

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