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 |
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.
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)
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