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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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
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 3:
* EEG at some time in past demonstrating focal abnormalities consistent with partial seizures
* If the EEG is inconclusive or does not support partial seizures, then an MRI/CT will be done
* If the MRI/CT fails to support a diagnosis of partial seizures, the subject may still qualify based on the principal Investigator's clinical diagnosis
* Subject weighs at least 15 kg (33 lbs).
* Parent/caregiver is able to keep an accurate seizure diary.
Exclusion Criteria
* Has a history of any of: 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
* Receiving systemic chemotherapy
* Requires treatment with aspirin
* Subject is pregnant
* 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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Global Medical Information 800-633-9110
Role: STUDY_DIRECTOR
Abbott
Locations
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Neurology Clinic, P.C.
Northport, Alabama, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
Child Neurology Associates, P.C.
Atlanta, Georgia, United States
Akron Children's Hospital
Akron, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Texas Association of Pediatric Neurology, P.A.
San Antonio, Texas, United States
Monarch Medical Research
Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Richard V. Colan, M.D., S.C.
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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M04-714
Identifier Type: -
Identifier Source: org_study_id