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A Study for 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: NCT00102713
Recruitment Status : Completed
First Posted : February 2, 2005
Last Update Posted : May 21, 2007
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Brief Summary:
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 or disease Intervention/treatment Phase
Partial Seizures Drug: Divalproex Sodium (Depakote Sprinkle Capsules) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study for Treatment of Partial Seizures in Children
Study Start Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Primary Outcome Measures :
  1. Partial Seizure Rate at Week 4

Secondary Outcome Measures :
  1. Adverse Events
  2. WASI
  4. BASC
  5. UKU-Neurologic Assessment
  6. Vital Signs
  7. Clinical Laboratory Assessments
  8. ECG
  9. PK analysis

Information from the National Library of Medicine

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

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)

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): NCT00102713

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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
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Study Director: Global Medical Information 800-633-9110 Abbott
Layout table for additonal information Identifier: NCT00102713    
Other Study ID Numbers: M04-714
First Posted: February 2, 2005    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007
Keywords provided by Abbott:
Partial Seizures
Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases
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