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Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00646711
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
10
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Depakote Delayed-Release/Depakote Sprinkle
  • Drug: Depakote ER
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Feb 1, 2003
Actual Primary Completion Date :
Dec 1, 2003
Actual Study Completion Date :
Dec 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence Group I

Depakote Delayed Release/Depakote Sprinkle

Drug: Depakote Delayed-Release/Depakote Sprinkle
Administered according to the subject's usual regimen.
Other Names:
  • ABT-711
  • Depakote DR
  • Depakote Sprinkle
  • divalproex sodium

    		•
    Experimental: Sequence Group II

    Depakote ER

    Drug: Depakote ER
    Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
    Other Names:
  • ABT-711
  • Depakote Extended Release
  • divalproex sodium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of seizures [2 weeks]

    2. Number of Adverse Events [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Richmond Virginia United States 23284

    Sponsors and Collaborators

    • Abbott

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00646711
    Other Study ID Numbers:
    • M02-461
    First Posted:
    Mar 28, 2008
    Last Update Posted:
    Mar 28, 2008
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Epilepsy
    Valproic Acid

    Study Results

    No Results Posted as of Mar 28, 2008