Pediatric Epilepsy Study in Subjects 1-24 Months

Study Overview
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Brief Summary
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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.

Official Title
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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)

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: 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.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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 |
| --- | --- | --- |
| Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation |  | 43 Months | 
| Change from baseline in vital signs -heart rate (HR) |  | Up to 43 Months | 
| Change from baseline in vital signs - weight (WT) |  | Up to 43 months | 
| Change from baseline in vital signs - height (HT) |  | Up to 43 months | 
| Change from baseline in vital signs - head circumference (HC) |  | Up to 43 months | 
| Change from baseline in clinical chemistry parameters including Albumin and Total protein |  | Up to month 43 | 
| Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST) |  | Up to 43 moths | 
| Change from baseline in clinical chemistry parameters including total bilirubin and creatinine |  | Up to 43 months | 
| Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea |  | Up to 43 months | 
| Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC) |  | Up to 43 moths | 
| Change from baseline in Hemoglobin (Hb) |  | Up to 43 months | 
| Change from baseline in Mean corpuscular hemoglobin (MCH) |  | Up to 43 months | 
| Change from baseline in Mean corpuscular hemoglobin concentration (MCHC) |  | Up to 43 months | 
| Change from baseline in mean corpuscular volume (MCv) |  | Up to 43 months | 
| Change from baseline in red blood cells (RBC) |  | Up to 43 months | 
| Number of participants with treatment emergent neurological abnormalities |  | Up to 43 months | 
| Number of participants with treatment emergent clinically significant ECG abnormalities |  | Up to 43 months | 
| Number of participants with potentially clinically significant change in hematology parameters |  | Up to 43 months | 
| Number of participants with potentially clinically significant change in clinical chemistry parameters |  | Up to 43 months | 
| Number of participants with potentially clinically significant change in vital signs |  | Up to 43 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase |  | Up to 48 Weeks | 
| Investigator's assessment of the participant's overall clinical status |  | Up to 43 months | 
| Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants |  | Week 6 | 

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