Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Verified by: Abbott, March 2008
First Received: March 25, 2008 | Last Updated: March 25, 2008 | Phase: Phase 2 | Start Date: February 2003
Overall Status: Completed | Estimated Enrollment: 16
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To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population...

Brief Summary

Official Title: “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”

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

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2003

Intervention(s) in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Sequence Group I
    • Depakote Delayed Release/Depakote Sprinkle
  • Experimental: Sequence Group II
    • Depakote ER

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of seizures
    • Time Frame: 2 weeks
      Safety Issue?: Yes
  • Number of Adverse Events
    • Time Frame: 2 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Abbott Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00646711

Study ID Number: M02-461

ClinicalTrials.gov Identifier: NCT00646711

Health Authority: United States: Food and Drug Administration

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