Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 6:03 PM
Study NCT ID:
NCT00021866
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2001-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study
Status:
COMPLETED
Status Verified Date:
2013-09
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:
The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?
Detailed Description:
This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2R01NS038455 | NIH | None | https://reporter.nih.gov/quic… | View |
| 2R01NS038455-06 | NIH | None | https://reporter.nih.gov/quic… | View |