Lacosamide IV and EEG/EKG (LIVE) Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.

Detailed Description
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The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. Information is lacking about the effect of lacosamide on brain and heart rhythms.

Official Title
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Lacosamide IV and EEG/EKG (LIVE) Study

Conditions
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Focal Epilepsy

Intervention / Treatment
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* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. Adult patients 18-65 years Diagnosis of focal epilepsy Continuous EEG and video monitoring Continuous EKG Active EEG showing frequent spikes, electrographic or clinical seizures Exclusion Criteria: Subject has no IV access. Subject is hemodynamically unstable. Previous use of Lacosamide Primary generalized epilepsy Non-epileptic seizures No significant cardiac, renal or hepatic disease No cardiac arrhythmias including heart block Subject is a pregnant or lactating woman.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 100 mg IV<br>100 mg IV lacosamide infused over 30 minutes | Drug: Lacosamide<br> <br> * Other names: Vimpat;|
| Other: 200 mg IV<br>200 mg IV lacosamide infused over 30 minutes | Drug: Lacosamide<br> <br> * Other names: Vimpat;|
| Other: 400 mg IV<br>400 mg IV lacosamide infused over 30 minutes | Drug: Lacosamide<br> <br> * Other names: Vimpat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of interictal spikes |  | One hour before and after drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency and quantity of background EEG rhythms |  | One hour before and after drug | 
| Change in EKG (QT, PR interval and heart rhythm) |  | One hour before and after drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV lacosamide, focal epilepsy, EEG, EKG