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Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646711
First Posted: March 28, 2008
Last Update Posted: March 28, 2008
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.
Information provided by:
Abbott
  Purpose
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

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

Enrollment: 16
Study Start Date: February 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00646711


Locations
United States, Virginia
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Abbott
  More Information

Responsible Party: Sharon Stec, Assoc Director, Abbott
ClinicalTrials.gov Identifier: NCT00646711     History of Changes
Other Study ID Numbers: M02-461
First Submitted: March 25, 2008
First Posted: March 28, 2008
Last Update Posted: March 28, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Anticonvulsants
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