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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT00021866
Eligibility Criteria:
* Subject must be diagnosed with partial seizures and/or secondary generalization or primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic seizures)
* Subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate monotherapy.
* Mothers must not have a history of drug abuse (including alcohol) in the last year and have no sequelae of drug abuse.
* Mothers must be able to maintain an accurate seizure diary of major motor seizures
* Subjects must have an IQ greater than or equal to 70 points.
* Subjects must have a history of a negative RPR and HIV.
* Subjects must not have progressive cerebral disease or presence of other major medical illness
* Subjects must not have exposure to known teratogens during pregnancy, except AEDs.
* Subjects must not have poor compliance with prenatal care.
* Subjects must have adequate reading skills to perform the cognitive tests.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00021866
Study Brief:
Protocol Section:
NCT00021866