Add on Lacosamide Versus High Dose Monotherapy

Completed · Phase 3

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01345058

Run by

Brigham and Women's Hospital

People needed

56

Starts

2011-08-01

Expected to finish

2014-10-21

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.