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

Partial Seizure Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00067431
• Other study ID #: M02-552
• Status: Terminated
• Phase: Phase 3
• First received: August 19, 2003
• Last updated: August 2, 2006
• Start date: July 2003

Study information

• Verified date: August 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Seizure Disorder
• Seizures

Intervention

Drug:
• Divalproex Sodium (Depakote® Sprinkle Capsules)

Locations

Country	Name	City	State
United States	Rainbow Babies Children's Hospital	Cleveland	Ohio
United States	University Hospital of Cleveland	Cleveland	Ohio
United States	PCTI / Children's Hospital	Columbus	Ohio
United States	Primary Physician's Research	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Texas Association of Pediatric Neurology, PA	San Antonio	Texas
United States	Pediatric Epilepsy & Neurology Specialist	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the 4-week partial seizure rate
Secondary	Adverse events
Secondary	Laboratory data
Secondary	Vital signs