A Study for Treatment of Partial Seizures in Children

Abbott

Status and phase

Completed

Phase 3

Conditions

Partial Seizures

Treatments

Drug: Divalproex Sodium (Depakote Sprinkle Capsules)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00102713

M04-714

Details and patient eligibility

About

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.

Sex

All

Ages

3 to 10 years old

Volunteers

No Healthy Volunteers

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)