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Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646711
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Pediatric Epilepsy Drug: Depakote Delayed-Release/Depakote Sprinkle Drug: Depakote ER Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Sequence Group I
Depakote Delayed Release/Depakote Sprinkle
Drug: Depakote Delayed-Release/Depakote Sprinkle
Administered according to the subject's usual regimen.
Other Names:
  • ABT-711
  • Depakote DR
  • Depakote Sprinkle
  • divalproex sodium

Experimental: Sequence Group II
Depakote ER
Drug: Depakote ER
Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
Other Names:
  • ABT-711
  • Depakote Extended Release
  • divalproex sodium

Primary Outcome Measures :
  1. Number of seizures [ Time Frame: 2 weeks ]
  2. Number of Adverse Events [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646711

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United States, Virginia
Richmond, Virginia, United States, 23284
Sponsors and Collaborators

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Responsible Party: Sharon Stec, Assoc Director, Abbott Identifier: NCT00646711    
Other Study ID Numbers: M02-461
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs