Pediatric Epilepsy
Conditions
Brief summary
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
Interventions
DRUGDepakote Delayed-Release/Depakote Sprinkle
Administered according to the subject's usual regimen.
DRUGDepakote ER
Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator. * Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization. * Minimum body weight of 37 lbs.
Exclusion criteria
* Six-month history of drug or alcohol abuse. * Status epilepticus within 6 months prior to screening. * Abnormal platelet or ALT/AST levels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of seizures | 2 weeks |
| Number of Adverse Events | 2 weeks |
Countries
United States
Outcome results
None listed