Add on Lacosamide Versus High Dose Monotherapy

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: lacosamide; Drug: levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT01345058

2010-P-001630

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults age 18 or older
2. 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
3. Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks
4. 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

1. Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy
2. Pregnant, child-bearing age not using contraception, or breast feeding
3. Medical contraindication to adding lacosamide
4. History of antiepileptic drug (AED) polytherapy
5. Presence of a vagus nerve stimulator
6. Creatinine clearance of less than 50 mL/min
7. Blood pressure instability: pulse <50 or >100, systolic blood pressure (SBP) <50 or >180, clinically significant electrocardiogram (EKG) abnormality
8. History of significant drug rash or anaphylactic reaction with antiepileptic drug
9. Patients with progressive lesions (e.g. brain tumors)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Lacosamide + Low-Dose Levetiracetam

Experimental group

Description:

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.

Treatment:

Drug: levetiracetam

Drug: lacosamide

Control Group (High-Dose Levetiracetam)

Other group

Description:

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.

Treatment:

Drug: levetiracetam