The Safety of Intravenous Lacosamide

Study Overview
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Brief Summary
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To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.

Detailed Description
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Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. A parenteral dosage form of Lacosamide is desirable for patients who are temporarily unable to take medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.

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: Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable. Patients may be male or female. Patients must be 4 years of age or older, and less than age 35 years. Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures. Exclusion Criteria: Patients will be excluded from entry into the study if any of the following are true: Patient has previously participated in any other intravenous Lacosamide study. Patient has status epilepticus within the last 3 months. Patient has a history of drug allergy to Lacosamide. Patient is pregnant. Patient has taken experimental drug within last 30 days. Patient with significant hepatic or renal 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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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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1A<br>Lacosamide, IV, 50 mg, once, 30 minutes | Drug: Lacosamide<br>* 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes<br>* Other names: Vimpat;|
| Active Comparator: Group 2A<br>Lacosamide, IV, 100 mg, once, 30 min | Drug: Lacosamide<br>* 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes<br>* Other names: Vimpat;|
| Active Comparator: Group 3A<br>Lacosamide, IV, 150 mg, once, 30 min | Drug: Lacosamide<br>* 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes<br>* Other names: Vimpat;|
| Active Comparator: Group 4A<br>Lacosamide, IV, 200 mg, once, 30 min | Drug: Lacosamide<br>* 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes<br>* Other names: Vimpat;|
| Active Comparator: Group 1B<br>Lacosamide, IV, 50 mg, once, 15 min | Drug: Lacosamide<br>* 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes<br>* Other names: Vimpat;|
| Active Comparator: Group 2B<br>Lacosamide, IV, 100 mg, once, 15 min | Drug: Lacosamide<br>* 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes<br>* Other names: Vimpat;|
| Active Comparator: Group 3B<br>Lacosamide, IV, 150 mg, once, 15 min | Drug: Lacosamide<br>* 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes<br>* Other names: Vimpat;|
| Active Comparator: Group 4B<br>Lacosamide, IV, 200 mg, once, 15 min | Drug: Lacosamide<br>* 0.7 mg/kg (up to maximum of 50 mg) x 5 subjects x 30 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 30 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 30 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 30 minutes. 0.7 mg/kg (up to a maximum of 50 mg) x 5 subjects x 15 minutes; 1.4 mg/kg (up to a maximum of 100 mg) x 5 subjects x 15 minutes; 2.1 mg/kg (up to a maximum of 150 mg) x 5 subjects x 15 minutes; 2.9 mg/kg (up to a maximum of 200 mg) x 5 subjects x 15 minutes<br>* Other names: Vimpat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of IV Lacosamide given as a rapid infusion. | The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial, onset, epilepsy, pediatric, lacosamide, partial onset epilepsy, vimpat