A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children
NCT ID: NCT00067431
Last Updated: 2006-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
300 participants
INTERVENTIONAL
2003-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Divalproex Sodium (Depakote® Sprinkle Capsules)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
3 Years
10 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Principal Investigators
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Laura Redden, M.D., Ph.D.
Role: STUDY_DIRECTOR
Medical Director
Locations
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Pediatric Epilepsy & Neurology Specialist
Tampa, Florida, 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
Texas Association of Pediatric Neurology, PA
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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M02-552
Identifier Type: -
Identifier Source: org_study_id