A Study for Treatment of Partial Seizures in Children
- Conditions
- Partial Seizures
- Registration Number
- NCT00102713
- Lead Sponsor
- Abbott
- Brief Summary
The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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 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.
- Has had status epilepticus in the past 3 months prior to Screening
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Partial Seizure Rate at Week 4
- Secondary Outcome Measures
Name Time Method Vital Signs PK analysis WASI UKU-Neurologic Assessment ECG WPPSI-III BASC Adverse Events Clinical Laboratory Assessments
Trial Locations
- Locations (10)
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Richard V. Colan, M.D., S.C.
🇺🇸Milwaukee, Wisconsin, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Texas Association of Pediatric Neurology, P.A.
🇺🇸San Antonio, Texas, United States
Pediatric Epilepsy and Neurology Specialists
🇺🇸Tampa, Florida, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Neurology Clinic, P.C.
🇺🇸Northport, Alabama, United States
Child Neurology Associates, P.C.
🇺🇸Atlanta, Georgia, United States
Monarch Medical Research
🇺🇸Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States