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Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00646711
First received: March 25, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646711

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

No publications provided

Responsible Party: Sharon Stec, Assoc Director, Abbott
ClinicalTrials.gov Identifier: NCT00646711     History of Changes
Other Study ID Numbers: M02-461
Study First Received: March 25, 2008
Last Updated: March 25, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 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

ClinicalTrials.gov processed this record on May 23, 2013