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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT02088957
Eligibility Criteria:
Inclusion Criteria:
* Subjects ≥16 years. Subjects under 18 years may only be included where legally permitted and ethically accepted
* Subjects in the neurological intensive care unit (NICU) (or equivalent closely monitored environment) having brain insult including traumatic brain injury and having nonconvulsive electrographic seizures (NCES) confirmed by electroencephalogram (EEG), lasting a minimum of 10 seconds but not \>30 minutes (minimum of 1 seizure in the last 6 hours) and treatment with an antiepileptic drug (AED) is required according to the physician's clinical judgment
* Subject is expected to be under cEEG monitoring with video surveillance in the Neuro ICU for at least 36 hours from the first administration of study drug
Exclusion Criteria:
* Subject has history of severe adverse hematologic or cutaneous reaction to any drug
* Subject presenting with status epilepticus or nonconvulsive status epilepticus (NCSE) (ie, 1 continuous, convulsive or nonconvulsive, unremitting seizure lasting \>30 minutes during Visit 1)
* Subject has been diagnosed with anoxic brain injury
* Subject has a known history of status epilepticus during the 6 months preceding Visit 1
* Subject is currently treated with Levetiracetam (LEV) or Phenytoin (PHT) or has been treated within the last 30 days before Visit 1 with LEV or PHT
* Subject is on felbamate with \<18 months' exposure before Visit 1
* Subject has presence of any sign (clinical or imaging techniques) suggesting a rapidly progressing process such that the subject is not expected to survive \>48 hours
* Subject has any clinical condition that would impair reliable participation in the study or necessitate the use of medications not allowed by the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02088957
Study Brief:
Protocol Section:
NCT02088957