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Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Information source: Abbott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pediatric Epilepsy

Intervention: Depakote Delayed-Release/Depakote Sprinkle (Drug); Depakote ER (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Abbott

Summary

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

Clinical Details

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

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

Primary outcome:

Number of seizures

Number of Adverse Events

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Richmond, Virginia 23284, United States
Additional Information

Starting date: February 2003
Last updated: March 25, 2008

Page last updated: August 20, 2015

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