A Study for Treatment of Partial Seizures in Children

Completed · Phase 3

Conditions studied: Partial Seizures

In brief

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.

Key facts

Study ID

NCT00102713

Run by

Abbott

People needed

50

Starts

2005-02-01

Last updated by the study team

2007-05-21

Who can join

Age: 3 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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