Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Phase 2

Completed

• Conditions: Pediatric Epilepsy
• Interventions: Drug: Depakote Delayed-Release/Depakote Sprinkle; Drug: Depakote ER

• Registration Number: NCT00646711
• Lead Sponsor: Abbott

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Status Verified: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Last Update Submitted: 2008-03-25
• Study First Posted: 2008-03-28
• Last Update Posted: 2008-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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Exclusion Criteria

• Six-month history of drug or alcohol abuse.
• Status epilepticus within 6 months prior to screening.
• Abnormal platelet or ALT/AST levels.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence Group I	Depakote Delayed-Release/Depakote Sprinkle	Depakote Delayed Release/Depakote Sprinkle
Sequence Group II	Depakote ER	Depakote ER

Primary Outcome Measures

Name	Time	Method
Number of seizures	2 weeks
Number of Adverse Events	2 weeks