NCT00646711

Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

A 14 Day Randomized, Open-Label, Cross-Over, Single Center, Outpatient Study of Depakote Delayed-Release or Depakote Sprinkle vs. Divalproex Sodium Extended-Release in Child and Adolescent Patients With Epilepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.

Conditions

• Pediatric Epilepsy

Interventions

Type	Name	Description
DRUG	Depakote Delayed-Release/Depakote Sprinkle	Administered according to the subject's usual regimen.
DRUG	Depakote ER	Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.

Timeline

• Start date: 2003-02-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2008-03-28
• Last updated: 2008-03-28

Locations

1 site across 1 country: United States