Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy

Study Overview
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Brief Summary
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This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment regimen.

Official Title
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A Non-interventional, Observational Study Evaluating Changes in Drug Load and Seizure Frequency Using Vimpat (Lacosamide) in Daily Clinical Practice in Combination Therapy With Sodium Channel Blocking Anti-epileptic Drugs (AEDs) or Non Sodium Channel Blocking AEDs

Conditions
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Focal Epilepsy With and Without Secondary Generalization

Intervention / Treatment
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* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has not received Vimpat® more than 7 days prior to start of Non-Interventional Study (NIS) The patient must have a diagnosis of epilepsy with partial-onset seizures with or without secondary generalization Based on the physician's clinical judgment, it is in the patient's best interest to be prescribed adjunctive Vimpat® (ie, the decision to prescribe Vimpat® is made by the physician) Patient must be at least 18 years of age The patient must have had at least one seizure within the last 3 months prior to enrolment

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vimpat + Na Channel Blocking AED<br>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED. | Drug: Lacosamide<br>* Route of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml).<br>* Other names: LCM;|
| Vimpat + Non-Na Channel Blocking AED<br>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED. | Drug: Lacosamide<br>* Route of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml).<br>* Other names: LCM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months) | Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs. | From Baseline (Day 0) to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lacosamide, Focal Epilepsy, Drug Load, AED, SP1065, Vimpat