Status:
COMPLETED
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
Lead Sponsor:
Abbott
Conditions:
Pediatric Epilepsy
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
Eligibility Criteria
Inclusion
- 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
- Six-month history of drug or alcohol abuse.
- Status epilepticus within 6 months prior to screening.
- Abnormal platelet or ALT/AST levels.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00646711
Start Date
February 1 2003
End Date
December 1 2003
Last Update
March 28 2008
Active Locations (1)
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1
Richmond, Virginia, United States, 23284