Pediatric Epilepsy Trial in Subjects 1-24 Months

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00043875

Enrollment

177

Registered

2002-08-15

Start date

2000-05-31

Completion date

2003-11-30

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

partial seizures, pediatric, epilepsy

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.

Interventions

DRUGlamotrigine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

1 Months to 24 Months

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	36 Months

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026