Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Study Identifier
M02-461
CT.gov Identifier
NCT00646711
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Neuroscience - Other
    • Study Drug
  • Depakote Delayed-Release/Depakote Sprinkle
  • Depakote ER
    • Phase
    CSR.ORG
    Sex
    Female & Male
    Age
    6 - 17 Years
    Inclusion and Exclusion 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.

    Protocol Summary

    To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets

    to Depakote ER tablets in the pediatric population.

    Study Locations

    Location
    Status
    Location
    Richmond, Virginia, United States, 23284
    Status
    Not applicable