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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT00236756
Eligibility Criteria:
Inclusion Criteria:
* Body weight of at least 25 pounds
* diagnosis of Lennox-Gastaut syndrome and an electroencephalogram (EEG) with an abnormal pulsation pattern
* atypical absence seizures and drop attacks (i.e., tonic-atonic seizures) among other seizure types that could include tonic-clonic, myoclonic, and minor-motor
* at least 60 seizures during the month before baseline
* must be maintained on 1 or 2 antiepileptic drugs
* females must not have had their first menstrual period, or are physically incapable of child bearing, or if of child bearing potential, sexually abstinent, or using adequate contraceptive measures, and have a negative pregnancy test before study entry.
Exclusion Criteria:
* Patients whose seizures are due to a progressive disease (for example, active infection, cancer or metabolic disturbance)
* have a significant recent history (within 2 years) of medical diseases (respiratory, heart, gastrointestinal, blood diseases, rheumatic fever or cancer)
* history of alcohol or drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
30 Years
Study:
NCT00236756
Study Brief:
Protocol Section:
NCT00236756