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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00050934
Eligibility Criteria:
INCLUSION CRITERIA: To enter this study, patients must:
* Have a diagnosis of partial seizures
* Be willing to be hospitalized
* Weigh a minimum of 6.6 pounds
* Be taking a stable dose of one to two concomitant anti-epileptic medications
* Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease
* Have normal laboratory results
EXCLUSION CRITERIA: To enter this study, a patient must not have or be:
* Seizures caused by metabolic disturbance, toxic exposure, or active infection
* A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures)
* A history of status epilepticus within 30 days
* Seizures not related to epilepsy
* Frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam)
* Taking felbamate within 6 months
* Serum sodium levels \<135 mEq/L
* Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy
* A history of chronic infection (e.g., hepatitis or HIV)
* Significant electrocardiogram (ECG) abnormalities
* A nursing mother taking anti-convulsant drugs
* Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds
* Used experimental medication within 30 days of entering this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
3 Years
Study:
NCT00050934
Study Brief:
Protocol Section:
NCT00050934