NCT00102713

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2005

Completed
Last Updated

May 21, 2007

Status Verified

May 1, 2007

First QC Date

February 1, 2005

Last Update Submit

May 17, 2007

Conditions

Partial Seizures

Keywords

Partial Seizures

Outcome Measures

Primary Outcomes (1)

  • Partial Seizure Rate at Week 4

Secondary Outcomes (9)

  • Adverse Events

  • WASI

  • WPPSI-III

  • BASC

  • UKU-Neurologic Assessment

  • +4 more secondary outcomes

Interventions

Divalproex Sodium (Depakote Sprinkle Capsules)DRUG

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Neurology Clinic, P.C.

Northport, Alabama, United States

Location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, United States

Location

Child Neurology Associates, P.C.

Atlanta, Georgia, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308 1062, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Texas Association of Pediatric Neurology, P.A.

San Antonio, Texas, United States

Location

Monarch Medical Research

Norfolk, Virginia, 23510, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298-0211, United States

Location

Richard V. Colan, M.D., S.C.

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Seizures

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Global Medical Information 800-633-9110

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2005

First Posted

February 2, 2005

Study Start

February 1, 2005

Last Updated

May 21, 2007

Record last verified: 2007-05

Locations

US(10)