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A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients With Inadequately-controlled Partial Seizures.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
1 Month to 3 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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