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:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00655551
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
* Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial
* Acceptable candidate for venipuncture and intravenous (iv) infusion
* At least 1 partial seizure with motor component per 90 days
* Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type
Exclusion Criteria:
* Previous use of lacosamide
* History of primary generalized seizures
* History of status epilepticus within last 12 months
* History of cluster seizures during 8 week period prior to screening
* Non-epileptic events, including psychogenic seizures that could be confused with seizures
* Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening
* Received any rescue benzodiazepines more than once during the 28 days prior to screening
* Concomitant treatment of felbamate or previous felbamate therapy within last 6 months
* Prior or concomitant vigabatrin use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT00655551
Study Brief:
Protocol Section:
NCT00655551