Add on Lacosamide Versus High Dose Monotherapy

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Lacosamide + Low-Dose Levetiracetam	levetiracetam	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.
Control Group (High-Dose Levetiracetam)	levetiracetam	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.
Lacosamide + Low-Dose Levetiracetam	lacosamide	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Six Month Seizure Freedom	6 Months	Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.

Secondary Outcome Measures

Name	Time	Method
Time to First Seizure After Therapeutic Dose is Reached	6 Months	Time in days until the first seizure after the therapeutic dose is reached occurs.
Retention Rate	6 Months	Retention rate is defined as the percentage of participants who remained on the study drug after study completion.
Number of Seizure-Free Days	6 Months
Number of Participants With Treatment-Emergent Adverse Events (TEAE)	6 Months	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.