Pediatric Switch Study for Children and Adolescent Patients With Epilepsy - Tabular View

Tracking Information
First Received Date ^ICMJE	March 25, 2008
Last Updated Date	March 25, 2008
Start Date ^ICMJE	February 2003
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 25, 2008)	Number of seizures [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] Number of Adverse Events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
Official Title ^ICMJE	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
Brief Summary	To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Crossover Assignment, Safety Study
Condition ^ICMJE	Pediatric Epilepsy
Intervention ^ICMJE	Drug: Depakote Delayed-Release/Depakote Sprinkle Drug: Depakote ER
Study Arms / Comparison Groups	Experimental: Depakote Delayed Release/Depakote Sprinkle Experimental: Depakote ER
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	16
Completion Date	December 2003
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	6 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00646711
Responsible Party	Sharon Stec, Assoc Director, Abbott
Study ID Numbers ^ICMJE	M02-461
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP