IV Lacosamide: The Safety of Intravenous Lacosamide

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.

Detailed Description
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The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.

Official Title
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IV Lacosamide: The Safety of Intravenous Lacosamide

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: IV Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or LAR must sign informed consent Diagnosis of partial onset currently uncontrolled Patient must have received anti-epileptic drug therapy prior to initiation Patient must have a medical condition in which parental administration is desireable Male or female Ages 4-35 Exclusion Criteria: Patient has participated in a study involving IV Lacosamide Patient has had an episode of status epilepticus in the last 3 months Drug history to lacosamide pregnant or lactating If of child bearing age, must have pregnancy test Patient has participated in an experimental drug study in last 30 days Patients with significant active hepatic or renal disease. Patients with known cardiac disease.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>IV Lacosamide administered (intravenously) over 30 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1 mg/ kg and 2.9 mg/kg over 30 minutes. | Drug: IV Lacosamide<br>* Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.<br>* Other names: Vimpat;|
| Active Comparator: Group B<br>IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg | Drug: IV Lacosamide<br>* Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.<br>* Other names: Vimpat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events (TEAEs), reported or observed. | Bradycardia, hypotension, fatigue, nausea, somnolence. | 2 years | 
| Measure post-infusion lacosamide plasma concentrations | Serum lacosamide level drawn from the arm opposite intravenous infusion | 2 years | 
| Measure changes in EKG, PR interval | PR interval changes measured in seconds | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy