Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Abbott

Status and phase: Completed; Phase 2

Conditions: Pediatric Epilepsy

Treatments: Drug: Depakote ER; Drug: Depakote Delayed-Release/Depakote Sprinkle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646711

M02-461

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Sequence Group I

Experimental group

Description:

Depakote Delayed Release/Depakote Sprinkle

Treatment:

Drug: Depakote Delayed-Release/Depakote Sprinkle

Sequence Group II

Experimental group

Description:

Depakote ER

Treatment:

Drug: Depakote ER