Partial Seizures
Conditions
Keywords
Partial Seizures
Brief summary
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.
Interventions
DRUGDivalproex Sodium (Depakote Sprinkle Capsules)
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Partial Seizure Rate at Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| WASI | — |
| WPPSI-III | — |
| BASC | — |
| UKU-Neurologic Assessment | — |
| Adverse Events | — |
| Clinical Laboratory Assessments | — |
| ECG | — |
| PK analysis | — |
| Vital Signs | — |
Countries
United States
Outcome results
None listed