Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population

Completed · Phase 4

Conditions studied: Epilepsy, Mental Retardation, Developmental Disabilities

In brief

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 be taken every day. Most medications need to be taken 2 or 3 times per day. Some medications have slow release and only are taaken once per day. Medications with slow release usually come in capsule form and cannot be opened or chewed. This study investiates whether children with developmental delay can be taught how to swalow pills.

Key facts

Study ID

NCT00207935

Run by

Children's National Research Institute

People needed

20

Starts

2005-08-01

Expected to finish

2007-03-01

Last updated by the study team

2008-05-05

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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