Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Epilepsy
Intervention: Depakote Delayed-Release/Depakote Sprinkle (Drug); Depakote ER (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Abbott
Summary
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets
to Depakote ER tablets in the pediatric population.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Crossover Assignment, Safety Study
Primary outcome: Number of seizuresNumber of Adverse Events
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Richmond, Virginia 23284, United States
Additional Information
Starting date: February 2003
Ending date: December 2003
Last updated: March 25, 2008
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