A Study for Treatment of Partial Seizures in Children

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.

Official Title
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An Open Label Study for Treatment of Partial Seizures in Children

Conditions
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Partial Seizures

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 3: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures If the EEG is inconclusive or does not support partial seizures, then an MRI/CT will be done If the MRI/CT fails to support a diagnosis of partial seizures, the subject may still qualify based on the principal Investigator's clinical diagnosis Subject weighs at least 15 kg (33 lbs). Parent/caregiver is able to keep an accurate seizure diary. Exclusion Criteria: Has had status epilepticus in the past 3 months prior to Screening Has a history of any of: 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 Receiving systemic chemotherapy Requires treatment with aspirin Subject is pregnant 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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 |
| --- | --- | --- |
| Partial Seizure Rate at Week 4 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  |  | 
| WASI |  |  | 
| WPPSI-III |  |  | 
| BASC |  |  | 
| UKU-Neurologic Assessment |  |  | 
| Vital Signs |  |  | 
| Clinical Laboratory Assessments |  |  | 
| ECG |  |  | 
| PK analysis |  |  | 

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