Add on Lacosamide Versus High Dose Monotherapy

Study Overview
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Brief Summary
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This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.

Official Title
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Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: lacosamide
* Drug: levetiracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age 18 or older Determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks Breakthrough seizure while on stable dose (>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications) Exclusion Criteria: Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy Pregnant, child-bearing age not using contraception, or breast feeding Medical contraindication to adding lacosamide History of antiepileptic drug (AED) polytherapy Presence of a vagus nerve stimulator Creatinine clearance of less than 50 mL/min Blood pressure instability: pulse <50 or >100, systolic blood pressure (SBP) <50 or >180, clinically significant electrocardiogram (EKG) abnormality History of significant drug rash or anaphylactic reaction with antiepileptic drug Patients with progressive lesions (e.g. brain tumors)

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide + Low-Dose Levetiracetam<br>Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam. | Drug: lacosamide<br>* Lacosamide maximum of 200 mg/day, to be titrated as follows: Week 1: 50 mg twice a day Beginning Week 2: 100 mg twice a day.<br>* Other names: Vimpat;Drug: levetiracetam<br>* Low dose ≤1500 mg/day, High dose >1500 mg/day<br>|
| Other: Control Group (High-Dose Levetiracetam)<br>Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study. | Drug: levetiracetam<br>* Low dose ≤1500 mg/day, High dose >1500 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Six Month Seizure Freedom | Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Seizure-Free Days |  | 6 Months | 
| Time to First Seizure After Therapeutic Dose is Reached | Time in days until the first seizure after the therapeutic dose is reached occurs. | 6 Months | 
| Retention Rate | Retention rate is defined as the percentage of participants who remained on the study drug after study completion. | 6 Months | 
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, antiepileptic drug, polytherapy