NCT00067431

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.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
terminated

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

Study Start

First participant enrolled

July 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2003

Completed
Last Updated

August 4, 2006

Status Verified

August 1, 2006

First QC Date

August 19, 2003

Last Update Submit

August 2, 2006

Conditions

Partial Seizure Disorder

Keywords

Partial Seizures

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the 4-week partial seizure rate

Secondary Outcomes (3)

  • Adverse events

  • Laboratory data

  • Vital signs

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 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pediatric Epilepsy & Neurology Specialist

Tampa, Florida, 33607, United States

Location

Rainbow Babies Children's Hospital

Cleveland, Ohio, 44106, United States

Location

University Hospital of Cleveland

Cleveland, Ohio, United States

Location

PCTI / Children's Hospital

Columbus, Ohio, 43205, United States

Location

Primary Physician's Research

Pittsburgh, Pennsylvania, United States

Location

Texas Association of Pediatric Neurology, PA

San Antonio, Texas, 78258, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298-0211, United States

Location

MeSH Terms

Conditions

Epilepsies, PartialSeizures

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Laura Redden, M.D., Ph.D.

    Medical Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2003

First Posted

August 20, 2003

Study Start

July 1, 2003

Last Updated

August 4, 2006

Record last verified: 2006-08

Locations

US(7)