Back to resultsPediatric Switch Study for Children and Adolescent Patients With Epilepsy
Primary Purpose
Pediatric Epilepsy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Depakote Delayed-Release/Depakote Sprinkle
Depakote ER
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Epilepsy
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence Group I
Sequence Group II
Arm Description
Depakote Delayed Release/Depakote Sprinkle
Depakote ER
Outcomes
Primary Outcome Measures
Number of seizures
Number of Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646711
Brief Title
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
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 Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence Group I
Arm Type
Experimental
Arm Description
Depakote Delayed Release/Depakote Sprinkle
Arm Title
Sequence Group II
Arm Type
Experimental
Arm Description
Depakote ER
Intervention Type
Drug
Intervention Name(s)
Depakote Delayed-Release/Depakote Sprinkle
Other Intervention Name(s)
ABT-711, Depakote DR, Depakote Sprinkle, divalproex sodium
Intervention Description
Administered according to the subject's usual regimen.
Intervention Type
Drug
Intervention Name(s)
Depakote ER
Other Intervention Name(s)
ABT-711, Depakote Extended Release, divalproex sodium
Intervention Description
Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
Primary Outcome Measure Information:
Title
Number of seizures
Time Frame
2 weeks
Title
Number of Adverse Events
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
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