A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children

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: NCT00067431
Recruitment Status : Terminated
First Posted : August 20, 2003
Last Update Posted : August 4, 2006
Information provided by:

Brief Summary:
The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.

Condition or disease Intervention/treatment Phase
Partial Seizure Disorder Drug: Divalproex Sodium (Depakote® Sprinkle Capsules) Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
Study Start Date : July 2003

Primary Outcome Measures :
  1. Change from baseline in the 4-week partial seizure rate

Secondary Outcome Measures :
  1. Adverse events
  2. Laboratory data
  3. Vital signs

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Subject has diagnosis of partial seizures with/without secondary generalization, supported by:

  • Observed ictal events consistent with partial seizures: With/ without secondary generalization; Documented by reliable observers
  • 1 of following 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures
  • On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month
  • Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL
  • History of at least 4 partial seizures/month in 2 months prior to screening
  • Parent/caregiver is able to keep an accurate seizure diary


  • History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC)
  • Has had status epilepticus in the past 6 months
  • Has significant history of any of following that would confound study results: Cardiac (including clinically important abnormality on ECG); Renal; Psychiatric (including psychosurgery); Oncologic; Endocrine; Metabolic; Pancreatic; Hepatic disease (including clinical/serological history of hepatitis); Urea cycle disorder
  • Has: Expanding CNS neoplasm; Active CNS infection; Demyelinating disease; Degenerative neurological disease; Progressive encephalopathy; or any Progressive CNS disease
  • Has platelet count less than or equal to 100,000/mcL
  • Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening
  • Requires anticoagulant drug therapy
  • Not expected to be able to maintain same dose of all pre-study AEDs, excluding valproate, throughout study
  • Receiving systemic chemotherapy
  • Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening
  • Has been on ketogenic diet within 30 days prior to screening
  • Considered by investigator to be non-responder to valproate for treatment of epilepsy (e.g., Despite adequate trial with serum concentrations of 60 mcg/mL or greater, subject continues to have inadequate seizure control)

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): NCT00067431

United States, Florida
Pediatric Epilepsy & Neurology Specialist
Tampa, Florida, United States, 33607
United States, Ohio
Rainbow Babies Children's Hospital
Cleveland, Ohio, United States, 44106
University Hospital of Cleveland
Cleveland, Ohio, United States
PCTI / Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Primary Physician's Research
Pittsburgh, Pennsylvania, United States
United States, Texas
Texas Association of Pediatric Neurology, PA
San Antonio, Texas, United States, 78258
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0211
Sponsors and Collaborators
Study Director: Laura Redden, M.D., Ph.D. Medical Director Identifier: NCT00067431     History of Changes
Other Study ID Numbers: M02-552
First Posted: August 20, 2003    Key Record Dates
Last Update Posted: August 4, 2006
Last Verified: August 2006

Keywords provided by Abbott:
Partial Seizures

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
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