Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088452
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2004-07-26
Brief Title:
Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Status:
COMPLETED
Status Verified Date:
2017-02
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:
The purpose of this study is to determine the best initial treatment for childhood absence epilepsy
Detailed Description:
Childhood absence epilepsy CAE is a common pediatric epilepsy syndrome that affects 10 to 15 percent of all children with epilepsy Individuals with CAE have brief staring spell seizures that occur suddenly unpredictably and frequently throughout the day These seizures impair the childrens ability to learn and play and lead to higher injury rates
There are many medications used to treat seizures but only 3 generally are used as the first treatment for children with CAE ethosuximide lamotrigine and valproic acid The goal of this study is to determine which of these 3 medicines is the best first choice as treatment for children with CAE
Approximately 439 children recruited over a 3-year period at 32 medical centers in the US will take part in this 5-year study Participants will be randomly given one of the 3 common CAE treatments-ethosuximide lamotrigine or valproic acid-and will make regular visits to a clinic every 1 to 3 months for approximately 2 years During the visits participants will undergo regular testing to determine if the medicine is working to watch for side effects and to help researchers learn more about the responses to these medicines In addition researchers hope to develop methods that may be used in the future to help choose the best medicine for each individual diagnosed with CAE
Also included in the study will be pharmacokinetics and pharmacogenetics research Pharmacokinetics is the study of how the body absorbs distributes metabolizes and excretes drugs Pharmacogenetics is the study of genetic determinants of the response to drugs Knowledge gained from this study may lead to individualized treatment for children with CAE and may also be beneficial for other pediatric and adult seizure disorders
There are many medications used to treat seizures but only 3 generally are used as the first treatment for children with CAE ethosuximide lamotrigine and valproic acid The goal of this study is to determine which of these 3 medicines is the best first choice as treatment for children with CAE
Approximately 439 children recruited over a 3-year period at 32 medical centers in the US will take part in this 5-year study Participants will be randomly given one of the 3 common CAE treatments-ethosuximide lamotrigine or valproic acid-and will make regular visits to a clinic every 1 to 3 months for approximately 2 years During the visits participants will undergo regular testing to determine if the medicine is working to watch for side effects and to help researchers learn more about the responses to these medicines In addition researchers hope to develop methods that may be used in the future to help choose the best medicine for each individual diagnosed with CAE
Also included in the study will be pharmacokinetics and pharmacogenetics research Pharmacokinetics is the study of how the body absorbs distributes metabolizes and excretes drugs Pharmacogenetics is the study of genetic determinants of the response to drugs Knowledge gained from this study may lead to individualized treatment for children with CAE and may also be beneficial for other pediatric and adult seizure disorders
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01NS045803 | NIH | None | httpsreporternihgovquickSearchU01NS045803 |