Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Pediatric Epilepsy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646711
• Other study ID #: M02-461
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2008
• Last updated: March 25, 2008
• Start date: February 2003
• Est. completion date: December 2003

Study information

• Verified date: March 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Pediatric Epilepsy

Intervention

Drug:
• Depakote Delayed-Release/Depakote Sprinkle
Administered according to the subject's usual regimen.
• Depakote ER
Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of seizures		2 weeks	Yes
Primary	Number of Adverse Events		2 weeks	Yes