Status:
COMPLETED
A Study for Treatment of Partial Seizures in Children
Lead Sponsor:
Abbott
Conditions:
Partial Seizures
Eligibility:
All Genders
3-10 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00102713
Start Date
February 1 2005
Last Update
May 21 2007
Active Locations (10)
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1
Neurology Clinic, P.C.
Northport, Alabama, United States
2
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
3
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
4
Child Neurology Associates, P.C.
Atlanta, Georgia, United States