Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01345058
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01345058
Study Brief:
Protocol Section:
NCT01345058