A Study for Treatment of Partial Seizures in Children

May 17, 2007 updated by: Abbott

An Open Label Study for Treatment of Partial Seizures in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Northport, Alabama, United States
        • Neurology Clinic, P.C.
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
    • Florida
      • Tampa, Florida, United States
        • Pediatric Epilepsy and Neurology Specialists
    • Georgia
      • Atlanta, Georgia, United States
        • Child Neurology Associates, P.C.
    • Ohio
      • Akron, Ohio, United States, 44308 1062
        • Akron Children's Hospital
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Of Cleveland
    • Texas
      • San Antonio, Texas, United States
        • Texas Association of Pediatric Neurology, P.A.
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Monarch Medical Research
      • Richmond, Virginia, United States, 23298-0211
        • Virginia Commonwealth University Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Richard V. Colan, M.D., S.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Partial Seizure Rate at Week 4

Secondary Outcome Measures

Outcome Measure
Vital Signs
Adverse Events
ECG
WASI
WPPSI-III
BASC
UKU-Neurologic Assessment
Clinical Laboratory Assessments
PK analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Registration Dates

First Submitted

February 1, 2005

First Submitted That Met QC Criteria

February 1, 2005

First Posted (Estimate)

February 2, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2007

Last Update Submitted That Met QC Criteria

May 17, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M04-714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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