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

This study has been terminated.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00067431
First received: August 19, 2003
Last updated: August 2, 2006
Last verified: August 2006
  Purpose

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 Intervention Phase
Partial Seizure Disorder
Drug: Divalproex Sodium (Depakote® Sprinkle Capsules)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children

Resource links provided by NLM:


Further study details as provided by Abbott:

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

Secondary Outcome Measures:
  • Adverse events
  • Laboratory data
  • Vital signs

Estimated Enrollment: 300
Study Start Date: July 2003
  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

  • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067431

Locations
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
Abbott
Investigators
Study Director: Laura Redden, M.D., Ph.D. Medical Director
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00067431     History of Changes
Other Study ID Numbers: M02-552
Study First Received: August 19, 2003
Last Updated: August 2, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Partial Seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
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 September 22, 2014