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A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children

Primary Purpose

Partial Seizure Disorder

Status
Terminated
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 Seizure Disorder 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 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL History of at least 4 partial seizures/month in 2 months prior to screening Parent/caregiver is able to keep an accurate seizure diary EXCLUSION CRITERIA: History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC) Has had status epilepticus in the past 6 months Has significant history of any of following that would confound study results: 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 Not expected to be able to maintain same dose of all pre-study AEDs, excluding valproate, throughout study Receiving systemic chemotherapy Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening 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

  • Pediatric Epilepsy & Neurology Specialist
  • Rainbow Babies Children's Hospital
  • University Hospital of Cleveland
  • PCTI / Children's Hospital
  • Primary Physician's Research
  • Texas Association of Pediatric Neurology, PA
  • Virginia Commonwealth University

Outcomes

Primary Outcome Measures

Change from baseline in the 4-week partial seizure rate

Secondary Outcome Measures

Adverse events
Laboratory data
Vital signs

Full Information

First Posted
August 19, 2003
Last Updated
August 2, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00067431
Brief Title
A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
Official Title
A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Terminated
Study Start Date
July 2003 (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 this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium (Depakote® Sprinkle Capsules)
Primary Outcome Measure Information:
Title
Change from baseline in the 4-week partial seizure rate
Secondary Outcome Measure Information:
Title
Adverse events
Title
Laboratory data
Title
Vital signs

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 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL History of at least 4 partial seizures/month in 2 months prior to screening Parent/caregiver is able to keep an accurate seizure diary EXCLUSION CRITERIA: History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC) Has had status epilepticus in the past 6 months Has significant history of any of following that would confound study results: 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 Not expected to be able to maintain same dose of all pre-study AEDs, excluding valproate, throughout study Receiving systemic chemotherapy Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening 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
Laura Redden, M.D., Ph.D.
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Pediatric Epilepsy & Neurology Specialist
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Rainbow Babies Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University Hospital of Cleveland
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
PCTI / Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Primary Physician's Research
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Texas Association of Pediatric Neurology, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0211
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children

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