CompletedPhase 3

Add on Lacosamide Versus High Dose Monotherapy

United States56 participantsStarted 2011-08-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants Achieving Six Month Seizure Freedom

Timeframe: 6 Months

Trial details

NCT IDNCT01345058

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02-15

Results submitted2017-03-15

View on ClinicalTrials.gov More Epilepsy trials