MedPath

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

Phase 3
Terminated
Conditions
Partial Seizure Disorder
Registration Number
NCT00067431
Lead Sponsor
Abbott
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline in the 4-week partial seizure rate
Secondary Outcome Measures
NameTimeMethod
Adverse events
Laboratory data
Vital signs

Trial Locations

Locations (7)

Pediatric Epilepsy & Neurology Specialist

🇺🇸

Tampa, Florida, United States

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

Rainbow Babies Children's Hospital

🇺🇸

Cleveland, Ohio, United States

University Hospital of Cleveland

🇺🇸

Cleveland, Ohio, United States

Texas Association of Pediatric Neurology, PA

🇺🇸

San Antonio, Texas, United States

PCTI / Children's Hospital

🇺🇸

Columbus, Ohio, United States

Primary Physician's Research

🇺🇸

Pittsburgh, Pennsylvania, United States

© Copyright 2025. All Rights Reserved by MedPath