A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children - Full Text View

Purpose

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.

Condition	Intervention	Phase
Partial Seizure Disorder	Drug: Divalproex Sodium (Depakote® Sprinkle Capsules)	Phase III

Genetics Home Reference related topics:

autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics:

Epilepsy Seizures

Drug Information available for:

Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Abbott:

Primary Outcome Measures:

Change from baseline in the 4-week partial seizure rate

Secondary Outcome Measures:

Adverse events
Laboratory data
Vital signs

Estimated Enrollment:	300
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	3 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067431

Locations


United States, Florida
	Pediatric Epilepsy & Neurology Specialist
	Tampa, Florida, United States, 33607

United States, Ohio
	PCTI / Children's Hospital
	Columbus, Ohio, United States, 43205
	University Hospital of Cleveland
	Cleveland, Ohio, United States
	Rainbow Babies Children's Hospital
	Cleveland, Ohio, United States, 44106

United States, Pennsylvania
	Primary Physician's Research
	Pittsburgh, Pennsylvania, United States

United States, Texas
	Texas Association of Pediatric Neurology, PA
	San Antonio, Texas, United States, 78258

United States, Virginia
	Virginia Commonwealth University
	Richmond, Virginia, United States, 23298-0211

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Laura Redden, M.D., Ph.D.	Medical Director

More Information

Study ID Numbers:	M02-552
First Received:	August 19, 2003
Last Updated:	August 2, 2006
ClinicalTrials.gov Identifier:	NCT00067431
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Partial Seizures

Study placed in the following topic categories:

Epilepsies, Partial

Signs and Symptoms

Epilepsy

Seizures

Neurologic Manifestations

Central Nervous System Diseases

Brain Diseases

Valproic Acid

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Antimanic Agents

Pharmacologic Actions

Therapeutic Uses

GABA Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00067431