Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

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

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Key information

Conditions

Pediatric Epilepsy

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Richmond, Virginia, 23284, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Depakote Delayed-Release/Depakote Sprinkle

Drug

Administered according to the subject's usual regimen.

Other names: ABT-711, Depakote DR, Depakote Sprinkle, divalproex sodium

Depakote ER

Drug

Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.

Other names: ABT-711, Depakote Extended Release, divalproex sodium

Primary outcomes

Number of seizures

Time frame: 2 weeks
Number of Adverse Events

Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Mar 28, 2008
Registry last updated: Mar 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed