A Study for Treatment of Partial Seizures in Children

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Valproic Acid

Criteria

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)