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A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children | Clinical Trials | Clareo Health

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

NCT00067431•Abbott

View on ClinicalTrials.gov

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.

Eligibility

Age

3 - 10 years

Sex

ALL

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
+2 more criteria

Locations (7)

Pediatric Epilepsy & Neurology Specialist

Tampa, Florida, United States

Rainbow Babies Children's Hospital

Cleveland, Ohio, United States

University Hospital of Cleveland

Cleveland, Ohio, United States

PCTI / Children's Hospital

Columbus, Ohio, United States

Primary Physician's Research

Pittsburgh, Pennsylvania, United States

Texas Association of Pediatric Neurology, PA

San Antonio, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

July 1, 2003

Last Updated

August 4, 2006

Enrollment

300

Estimated participants

Conditions

Partial Seizure Disorder

Interventions

Divalproex Sodium (Depakote® Sprinkle Capsules)

DRUG