Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Valproic Acid

Criteria

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.