Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Completed · Phase 2

Conditions studied: Pediatric Epilepsy

In brief

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

Key facts

Study ID

NCT00646711

Run by

Abbott

People needed

16

Starts

2003-02-01

Expected to finish

2003-12-01

Last updated by the study team

2008-03-28

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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