Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population
Condition: Epilepsy; Mental Retardation; Developmental Disabilities
MeSH terms: Epilepsy; Intellectual Disability; Developmental Disabilities
Study type: Interventional
Phase: Phase 4

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 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.
    

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 localization, and additional medication treatment status for the duration of the
      study will be established. IQ status which has been done (either by the school system or as
      part of a developmental assessment,) will be used.

      Behavioral status will be verified and related to seizure activity as well. Behavioral
      measures will include the Vineland (a measure of life skills assessment) and the Child
      Behavior Checklist. Participants then return for a study visit two weeks later. At that time
      initial laboratory tests will be done including a trough level of valproic acid. Pregnancy
      tests will be done on all females of childbearing potential, because of the known risk of
      valproic acid during pregnancy. Participants will return for a third study visit two weeks
      later where another trough valproic acid level will be obtained, and effective dosage
      conversion of Depakote® Sprinkle to Depakote® ER will occur. Subsequent study visits will
      occur at weeks 6 and 8 (2 and 4 weeks respectively, after the dose conversion); trough
      valproic acid levels will be obtained each time. At each study visit, neurologic (seizure
      control) and behavioral status will be reviewed as well as monitoring for side effects and
      adverse events. Each study visit will also include instruction and coaching regarding
      strategies for pill swallowing and other aspects of adherence to treatment regimen.
      Compliance will be ascertained by means of drug level monitoring pre and post dosage
      conversion. Clinical global improvement in functioning for both behavioral issues and
      epilepsy will be assessed.

      The study will conclude after the 5th visit.

      Table of Events Visit 1 2 3 4 5 Day -28 -14 0 14 28 Week -4 -2 0 2 4 Informed Consent X
      Eligibility Criteria X X Demographics X Medical and Surgical History X IQ verification X
      QOLIE X X Vineland X X CBCL X X Seizure assessment X X X X X Physical and Neurologic exam X X
      X VS X X X Lab assessments X X
    

Intervention name(s): Swallow instruction
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizures; Depakote; Developmental Delay; Mental Retardation; Swallow