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

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ClinicalTrials.gov Identifier: NCT00207935
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 5, 2008
Sponsor:
Information provided by:
Children's Research Institute

September 14, 2005
September 21, 2005
May 5, 2008
August 2005
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Ability to swallow capsules in a mentally retarted developmentally delayed population
Same as current
Complete list of historical versions of study NCT00207935 on ClinicalTrials.gov Archive Site
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Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population
Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population
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.

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

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Epilepsy
  • Mental Retardation
  • Developmental Disabilities
Behavioral: Swallow instruction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
March 2007
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Inclusion Criteria:

  1. Age 4-18 years, inclusive.
  2. Clinical Diagnosis of Partial or Primary Generalized Seizure Disorder
  3. Documented IQ scores in the range of borderline, mild, moderate, or severe mental retardation (IQ<80).
  4. 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.
  5. Subject's parent or guardian must be capable of maintaining a record of dosing times, seizure characteristics, and adverse events.

Exclusion Criteria:

  1. Oral Motor Dysfunction to the degree that swallowing is affected.
  2. History of significant aspiration.
  3. Serious medical conditions such as cancer, pancreatitis, diabetes, HIV.
  4. 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).
  5. History of metabolic disorders including urea cycle disorders.
  6. Pregnancy

Sexes Eligible for Study: All
4 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00207935
CNMC IRB 3579
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Children's Research Institute
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Principal Investigator: Joan A Conry, MD Children's Research Institute
Children's Research Institute
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP