Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Madera, California 93638


Purpose:

This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.


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


NCT ID:

NCT00050934


Primary Contact:

Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Madera, California 93638
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.