Add on Lacosamide Versus High Dose Monotherapy

• Status: Completed
• Trial end date: 2014-10-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Etiracetam; Lacosamide; Levetiracetam; Piracetam

Criteria

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)