Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207935
Status:
COMPLETED
Last Update Posted:
2008-05-05
First Post:
2005-09-14
Brief Title:
Use of Sustained Release Antiepileptic Medication Depakote ER for Pediatric Epilepsy in a Mental RetardationDevelopmental Disorder Population
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Use of Sustained Release Antiepileptic Medication Depakote ER for Pediatric Epilepsy in a Mental RetardationDevelopmental Disorder Population
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None