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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT01545518
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months.
* Age 18 to 50.
* Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy.
* Refractory to an adequate trial of two or more main-line anti-epileptic drugs.
* Ability to keep a seizure diary.
* Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the exception of hippocampal sclerosis
Exclusion Criteria:
* History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects.
* Evidence of psychogenic epilepsy.
* History of convulsive status epilepticus.
* History of primary generalized epilepsy in a first degree relative.
* Known serious medical illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01545518
Study Brief:
Protocol Section:
NCT01545518