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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT00236704
Eligibility Criteria:
Inclusion Criteria:
* Body weight \>25 kilograms (55 pounds)
* diagnosis of primary generalized epilepsy
* must have primary generalized tonic-clonic (PGTC) seizures treated with 1 or 2 antiepileptic drugs
* must have three primary generalized tonic-clonic (PGTC) seizures during baseline period, with at least 1 during each 28-day period of baseline
* females must not have had their first menstrual period or be postmenopausal, or are physically incapable of child bearing, or if of child bearing potential, sexually abstinent, or using adequate birth control measures, and have a negative pregnancy test before study entry.
Exclusion Criteria:
* Patients who do not have epilepsy, such as those with a treatable cause of seizure (for example active infection or cancer)
* patients with progressive disorders (for example, active infection, cancer or metabolic disturbance)
* patients diagnosed with Lennox-Gastaut syndrome
* history of seizures occurring in only cluster patterns (numerous seizures occurring over a short period of time \[\<30 minutes\])
* documented history (previous 3 months) of generalized tonic-clonic status epilepticus (status epilepticus is a prolonged seizure or seizures repeated frequently over 20 to 30 minutes so that recovery between episodes does not occur) while receiving appropriate antiepileptic medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT00236704
Study Brief:
Protocol Section:
NCT00236704