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

Study Overview
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Brief Summary
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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.

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

Conditions
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Partial Seizure Disorder

Intervention / Treatment
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* Drug: Divalproex Sodium (Depakote® Sprinkle Capsules)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Divalproex Sodium (Depakote® Sprinkle Capsules)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the 4-week partial seizure rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Laboratory data |  |  | 
| Vital signs |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial Seizures