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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01627860
Eligibility Criteria:
Inclusion Criteria:
* Must be diagnosed with seizure disorder
* Have been receiving concomitant therapy with one antiepileptic drug (AED), at stable dose prior to trial entry
* Must be dissatisfied with the current treatment
Exclusion Criteria:
* Have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active infection, or neoplasm)
* Have grade IV astrocytomas, eg, Glioblastoma multiforme (GBM) or metastases with progression
* Have seizures occurring only in clustered patterns defined as numerous seizures occurring in less than 30 min
* Have had history (within past six months) of a psychiatric or mood disorder requiring electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors
* Have had schizophrenic or history of exhibiting psychotic symptomatology
* Inability to take medication or maintain a seizure calendar, independently or with assistance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01627860
Study Brief:
Protocol Section:
NCT01627860