Clinical trial NCT00067431: A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
Official title: A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Partial Seizure Disorder
Keywords: Partial Seizures
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-08-20
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Change from baseline in the 4-week partial seizure rate
Secondary outcomes:
measure: Adverse events
measure: Laboratory data
measure: Vital signs
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Pediatric Epilepsy & Neurology Specialist
state: Florida
city: Cleveland
country: United States
facility: Rainbow Babies Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospital of Cleveland
state: Ohio
city: Columbus
country: United States
facility: PCTI / Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Primary Physician's Research
state: Pennsylvania
city: San Antonio
country: United States
facility: Texas Association of Pediatric Neurology, PA
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Medical Director
name: Laura Redden, M.D., Ph.D.
role: STUDY_DIRECTOR
References: