Status:
COMPLETED
Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population
Lead Sponsor:
Children's National Research Institute
Conditions:
Epilepsy
Mental Retardation
Eligibility:
All Genders
4-18 years
Phase:
PHASE4
Brief Summary
This study is being done to see if children with learning problems can learn how to swallow pills without chewing them. The reason this is important is that if a person has seizures, medications must ...
Detailed Description
Participants will initially be consented into the study, and receive baseline assessments. At the baseline visit, seizure types (partial, primary generalized, secondary generalized), seizure foci loca...
Eligibility Criteria
Inclusion
- Age 4-18 years, inclusive.
- Clinical Diagnosis of Partial or Primary Generalized Seizure Disorder
- Documented IQ scores in the range of borderline, mild, moderate, or severe mental retardation (IQ\<80).
- Currently Treatment regimen includes Depakote® Sprinkles either as monotherapy or adjunctive therapy. Dosages should have been stable for at least 4 weeks prior to baseline.
- Subject's parent or guardian must be capable of maintaining a record of dosing times, seizure characteristics, and adverse events.
Exclusion
- Oral Motor Dysfunction to the degree that swallowing is affected.
- History of significant aspiration.
- Serious medical conditions such as cancer, pancreatitis, diabetes, HIV.
- History of hepatic dysfunction including history of elevated liver enzymes (AST or ALT values greater or equal to three times the upper limit of normal).
- History of metabolic disorders including urea cycle disorders.
- Pregnancy
- \-
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00207935
Start Date
August 1 2005
End Date
March 1 2007
Last Update
May 5 2008
Active Locations (1)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010