NCT00646711CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 16
- Primary Endpoint
- Number of seizures
Study Overview
Brief Summary
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- 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.
Arms & Interventions
Sequence Group I
Experimental
Depakote Delayed Release/Depakote Sprinkle
Intervention: Depakote Delayed-Release/Depakote Sprinkle (Drug)
Sequence Group II
Experimental
Depakote ER
Intervention: Depakote ER (Drug)
Outcomes
Primary Outcomes
Number of seizures
Time Frame: 2 weeks
Number of Adverse Events
Time Frame: 2 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
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Unknown
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