Pediatric Epilepsy Trial in Subjects 1-24 Months

Study Overview
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Brief Summary
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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.

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

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: lamotrigine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lamotrigine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial seizures, pediatric, epilepsy