A Study for Treatment of Partial Seizures in Children

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00102713
First received: February 1, 2005
Last updated: May 17, 2007
Last verified: May 2007
  Purpose

The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.


Condition Intervention Phase
Partial Seizures
Drug: Divalproex Sodium (Depakote Sprinkle Capsules)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study for Treatment of Partial Seizures in Children

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Partial Seizure Rate at Week 4

Secondary Outcome Measures:
  • Adverse Events
  • WASI
  • WPPSI-III
  • BASC
  • UKU-Neurologic Assessment
  • Vital Signs
  • Clinical Laboratory Assessments
  • ECG
  • PK analysis

Estimated Enrollment: 50
Study Start Date: February 2005
  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 3:

    • EEG at some time in past demonstrating focal abnormalities consistent with partial seizures
    • If the EEG is inconclusive or does not support partial seizures, then an MRI/CT will be done
    • If the MRI/CT fails to support a diagnosis of partial seizures, the subject may still qualify based on the principal Investigator's clinical diagnosis
  • Subject weighs at least 15 kg (33 lbs).
  • Parent/caregiver is able to keep an accurate seizure diary.

Exclusion Criteria:

  • Has had status epilepticus in the past 3 months prior to Screening
  • Has a history of any of: 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
  • Receiving systemic chemotherapy
  • Requires treatment with aspirin
  • Subject is pregnant
  • 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: NCT00102713

Locations
United States, Alabama
Neurology Clinic, P.C.
Northport, Alabama, United States
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, Florida
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
United States, Georgia
Child Neurology Associates, P.C.
Atlanta, Georgia, United States
United States, Ohio
Akron Children’s Hospital
Akron, Ohio, United States, 44308 1062
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
Texas Association of Pediatric Neurology, P.A.
San Antonio, Texas, United States
United States, Virginia
Monarch Medical Research
Norfolk, Virginia, United States, 23510
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298-0211
United States, Wisconsin
Richard V. Colan, M.D., S.C.
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information 800-633-9110 Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00102713     History of Changes
Other Study ID Numbers: M04-714
Study First Received: February 1, 2005
Last Updated: May 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Partial Seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
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 July 31, 2014