A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children

Abbott

Status and phase

Terminated

Phase 3

Conditions

Partial Seizure Disorder

Treatments

Drug: Divalproex Sodium (Depakote® Sprinkle Capsules)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00067431

M02-552

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.

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 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures
On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month
Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL
History of at least 4 partial seizures/month in 2 months prior to screening
Parent/caregiver is able to keep an accurate seizure diary

Exclusion criteria

History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC)
Has had status epilepticus in the past 6 months
Has significant history of any of following that would confound study results: 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
Not expected to be able to maintain same dose of all pre-study AEDs, excluding valproate, throughout study
Receiving systemic chemotherapy
Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening
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)