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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT00160550
Eligibility Criteria:
Inclusion Criteria:
* Subject with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures (IIE) that are classifiable according to the ILAE Classification of Epileptic Seizures.
* Presence of at least 3 PGTC seizures during the 8-week combined Baseline period.
* Absence of brain lesion documented on a CT scan or MRI.
* An EEG performed within 1 year of Visit 1 with features consistent with PGTC seizures or generalized idiopathic epilepsy.
* Male/female subject, \>=4 or \<=65 years of age at Visit 1.
* Subject on a stable dose of one or two AEDs during baseline.
Exclusion Criteria:
* Previous exposure to levetiracetam.
* History of partial seizures.
* History of convulsive or non-convulsive status epilepticus while taking concomitant AEDs within three months prior to Visit 1.
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
65 Years
Study:
NCT00160550
Study Brief:
Protocol Section:
NCT00160550