Add on Lacosamide Versus High Dose Monotherapy



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:March 2011
End Date:February 2013
Contact:Jong Woo Lee, MD, PhD
Email:jlee38@partners.org
Phone:617-732-7547

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Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder

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.


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 1500mg/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 AED polytherapy

5. Presence of a vagus nerve stimulator

6. Creatinine clearance of less than 50mL/min

7. Blood pressure instability: pulse<50 or >100, SBP<50 or >180, clinically significant
EKG abnormality

8. History of significant drug rash or anaphylactic reaction with antiepileptic drug

9. Patients with progressive lesions (e.g. brain tumors)
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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mi
from
Boston, MA
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