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A Study for Treatment of Partial Seizures in Children

Primary Purpose

Partial Seizures

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Divalproex Sodium (Depakote Sprinkle Capsules)
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Seizures focused on measuring Partial Seizures

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Neurology Clinic, P.C.
  • St. Joseph's Hospital and Medical Center
  • Pediatric Epilepsy and Neurology Specialists
  • Child Neurology Associates, P.C.
  • Akron Children's Hospital
  • University Hospitals of Cleveland
  • Texas Association of Pediatric Neurology, P.A.
  • Monarch Medical Research
  • Virginia Commonwealth University Medical Center
  • Richard V. Colan, M.D., S.C.

Outcomes

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

Full Information

First Posted
February 1, 2005
Last Updated
May 17, 2007
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00102713
Brief Title
A Study for Treatment of Partial Seizures in Children
Official Title
An Open Label Study for Treatment of Partial Seizures in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Seizures
Keywords
Partial Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium (Depakote Sprinkle Capsules)
Primary Outcome Measure Information:
Title
Partial Seizure Rate at Week 4
Secondary Outcome Measure Information:
Title
Adverse Events
Title
WASI
Title
WPPSI-III
Title
BASC
Title
UKU-Neurologic Assessment
Title
Vital Signs
Title
Clinical Laboratory Assessments
Title
ECG
Title
PK analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information 800-633-9110
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Clinic, P.C.
City
Northport
State/Province
Alabama
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Pediatric Epilepsy and Neurology Specialists
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Child Neurology Associates, P.C.
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308 1062
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Texas Association of Pediatric Neurology, P.A.
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Monarch Medical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0211
Country
United States
Facility Name
Richard V. Colan, M.D., S.C.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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A Study for Treatment of Partial Seizures in Children

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