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

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: Divalproex Sodium (Depakote Sprinkle Capsules)

Primary Measures

• Partial Seizure Rate at Week 4

Secondary Measures

• Adverse Events
• WASI
• WPPSI-III
• BASC
• UKU-Neurologic Assessment
• Vital Signs
• Clinical Laboratory Assessments
• ECG
• PK analysis

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 10 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information 800-633-9110 Study Director Abbott  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00102713

Study ID Number: M04-714

ClinicalTrials.gov Identifier: NCT00102713

Health Authority: United States: Food and Drug Administration